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This text was designed by Becker (Becker & Associates Consu ... Read more

This text was designed by Becker (Becker & Associates Consulting Inc.) and Whyte (Discovery Health Channel) as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. The new edition has been updated to reflect technological and regulatory change and includes chapters on regulatory requirements for clinical studies of medical devices and diagnostics, requirements for Medicare coverage and reimbursement for medical devices, post-market requirements for significant risk devices, intellectual property protection for medical devices, compliance with the Health Insurance Portability and Accountability Act of 1996 in clinical research, developing drug-device combination products with unapproved component's, and Wall Street's perspective on medical device evaluation. It also contains nine case studies, all of which are new to this edition. Annotation ©2006 Book News, Inc., Portland, OR (booknews.com) Minimize

Medical Alert Emergency Wall Communicator. This wireless wa ... Read more

Medical Alert Emergency Wall Communicator. This wireless water-resistant device is designed to mount on a wall. Mount one next to the bed-side table or even next to the shower in the bathroom. These permanent communicators allow for full two-way voice communication anytime an emergency occurs. Particularly handy if one forgets to carry their pendant with then to the bathroom in the middle of the night. Operates in standby well over a year on 4 AAA alkaline batteries - and provides over 5 hours of talk time. Minimize

The ScootaTrailer, unlike any other mobility device carrier ... Read more

The ScootaTrailer, unlike any other mobility device carrier, lets you transport the largest scooters and power wheelchairs on compact and subcompact cars! This includes vehicles like the Chevy Cavalier, Chrysler PT Cruiser, Ford Focus, Honda Accord, and Toyota Corolla. In fact, any vehicle with a class one trailer hitch is compatible with the ScootaTrailer because it only places 35 to 75 pounds of weight onto the hitch. What are the advantages of the ScootaTrailer and its universal design? Here are just a few: You don't need to buy a larger vehicle just to transport your scooter, power chair, or other mobility device. You can save gas by using a smaller vehicle. You can easily switch the ScootaTrailer from vehicle to vehicle because of the included Swivel Trailer Jack. The ramp height is very low, making loading easier than traditional vehicle lifts. An optional gas-strut makes it even easier to lower the ramp. You can still access the rear hatch of vans & SUVs or the rear trunk of cars. Traditional external lifts require you purchase a swing-away arm. Completely stable at highway speeds, it even has its own VIN number! With the optional lockable cover you get complete protection for your device and gas-strut assistance. Can be detached easily and rolled away into a carport or shed. Overall, the ScootaTrailer is the ideal solution for transporting scooters, power wheelchairs, and even small off-road vehicles. It offers safety, convenience, and tremendous compatibility. Minimize

This title is part of the UniversityOfHealthCare/ Universit ... Read more

This title is part of the UniversityOfHealthCare/ UniversityOfBusiness Interactive Training Library, which offers authoritative, clearly written material in an interactive form for better comprehension and documentation of completion. Powerful Medical Device Sales is a comprehensive course with over 100 videos and animations for the medical device and pharmaceutical sales representative on sales skills to use with doctors and hospitals while observing correct procedures and building trust. It takes the attitude that consultative selling and considerate behavior create the most productive client relationships. It covers the structure of a hospital, medical staff, the hospital pharmacy, the hospital-based pharmacist, the nursing service, policies and procedures for hospital vendors, HIPAA essentials for the sales rep, sexual harassment, sales professionalism and building trust, customer management (with video interviews of doctors, a hospital pharmacist, and a medical assistant), and powerful sales communication (with a sales simulation). Estimated time: 10-20 hours. The course is divided into topics with their own tests so you can study and demonstrate your knowledge on different topics. The course results from the collaboration of an exceptional sales rep, a doctor, a nurse/MBA/marketing executive, and a media expert. 1228 pages on the CD. 126 pages in the manual. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. You will need Internet access to e-mail us your unique key and receive a password key. License is for one user on one computer. An additional computer owned by the same user will generally be approved at the discretion of the publisher. The manual accompanying the CD provides a summary of the major points of the CD in a handy format. Minimize

Medical devices and surgical tools that contain micro and n ... Read more

Medical devices and surgical tools that contain micro and nanoscale features allow surgeons to perform clinical procedures with greater precision and safety while monitoring physiological and biomechanical parameters more accurately. While surgeons have started to master the use of nanostructured surgical tools in the operating room, this book addresses for the first time the impact and interaction of nanomaterials and nanostructured coatings in a comprehensive manner.Surface Engineered Surgical Tools and Medical Devices presents the latest information and techniques in the emerging field of surface engineered biomedical devices and surgical tools, and analyzes the interaction between nanotechnology, nanomaterials, and tools for surgical applications. Chapters of the book describe developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. Chapters are also dedicated to the performance of surgica Minimize

Work Device A combination lifting box and push cart for wor ... Read more

Work Device A combination lifting box and push cart for work simulation, conditioning and evaluation. The box features a strap, foam covered hand grips and hand slots for lifting. The cart promotes push-pull activities and has an adjustable handle for height and angle. Removeable weight holder with weight keeper Natural finish Empty weight: 10 lbs (box) T-handle adjusts 32"-44" high Weight capacity: 80 lbs Dimensions: Box: 13 1/2" Square x 12" High Cart: 14 " W x 17" L x 4 3/4" H including 2" casters Minimize

Work DeviceA combination lifting box and push cart for work ... Read more

Work DeviceA combination lifting box and push cart for work simulation, conditioning and evaluation. The box features a strap, foam covered hand grips and hand slots for lifting. The cart promotes push-pull activities and has an adjustable handle for height and angle.Removeable weight holder with weight keeper.Natural finish.Empty weight: 10 lbs (box).T-handle adjusts 32"-44" high.Weight capacity: 80 lbs.Dimensions:Box: 13 1/2" Square X 12" HighCart: 14 " W X 17" L X 4 3/4" H including 2" casters Minimize

Spine-Worx is like having a Chiropractor in Your Home, and ... Read more

Spine-Worx is like having a Chiropractor in Your Home, and can help you be free of back pain in just 15 minutes a day! There is no reason to live with back pain. Thousands of people just like you have relieved their pain with this simple and effective home therapy product. Spine-Worx is a medical device which gently guides misaligned vertebrae into their correct positions and holds them there while tense muscles relax and stretch, to relieve back pain and related symptoms. ? Padded ridges and unique contours apply even pressure where it is needed ? Uses only your own body weight to control applied pressure ? Automatically matches each individual's requirements ? Feel fast relief. Remember: The central nervous system begins in the brain, courses into the spine and runs throughout the entire human body. If you shut down nerve supply, you shut down the body! Minimize

The AuraWave is a state of the art Class II Medical Device ... Read more

The AuraWave is a state of the art Class II Medical Device used to alleviate most types of pain, muscle aches and more. This item is the first FDA approved pain relief device for lower back and extremities available. Minimize

Product DescriptionThis bath and shower seat designed by wo ... Read more

Product DescriptionThis bath and shower seat designed by world renowned architect/designer Michael Graves features both beauty and functionality. The signature MG "Orange Activates" incorporated into Michael Graves designs allows for a visual pin point signifying easy operation. The orange buttons located on the legs allow for one step height adjustment. The enhanced comfort seat fits all shapes and sizes which features built-in handles, shower holder and drainage holes providing a wonderful bathing experience. The shower seat can withstand a capacity of 300 pounds.This clamp on tub rail designed by world renowned architect/designer Michael Graves features both beauty and functionality. The signature MG "Orange Activates" incorporated into Michael Graves designs allows for a visual pin point signifying easy operation. The orange turn knob is easy to adjust allowing for one step installation. The base clamp is width adjustable from 3"-7", fitting most standard-sized tubs. The greatest feature on the Michael Graves tub rail is the contoured soap and shampoo holder. Steel construction ensures durability while a clean white and blue/grey finish will complement any style bathroom. The oversized handle can be height adjusted from 14" - 17" for personal comfort ensuring optimum stability and security. Not only is this tub rail guaranteed to make your bathing experience more enjoyable but it won't scratch your tub and will ensure a safer and more comfortable bathing experience.Features and BenefitsMG12170: Large pins make height adjustment easyEasy tool free assembly and disassemblyEnhanced comfort seat fits all shapes and sizesLightweight design has large stable legs with soft non-slip feetSeat has built-in handles with hand-held shower holder and drainage holesWill not slip, slide or scratch tub.300lb. Weight capacityMG12050SC: MG Orange ActivatesTurn knob for easy adjustmentSoft cover for added safetyNon-slip comfort grip makes bathing safer and more comfortable for everyoneOversized handle provides additional stability, making bathing safe and secureEasy tool-free assemblyheight adjusts from 14" to 17"Width adjusts from 3" to 7"Integrated dishes for soap and shampooNo sharp edges makes bathing safer and more comfortable and wont scratch tubProduct SpecificationMG12170: Outside Legs (Width): 15.75".Outside Legs (Depth): 14.75".Seat (Width): 16".Seat (Depth): 16".Seat (Height): 16.5"-21.25".Product Weight: 7.5 lbs.MG12050SC: Adjustable Clamp: 3"-7".Tub Rail Height: 14"-17".Product Weight: 7.4 lbs.Model #MGK1 Minimize

With the Home Security Store Medical Alert, you can enjoy t ... Read more

With the Home Security Store Medical Alert, you can enjoy the freedom of independent living. There are no activation costs, no contracts, and no monthly fees. This system features 2-way voice communications through the pendant itself, making it unique over most personal emergency response systems (PERS) on the market today. The Medical Alert is simple to operate and easy to install. With it, you're only a push button away from contacting your four pre-programmed emergency contacts or 911. This unit allows users instant 2-way speaker phone communication through a mini and wearable pendant. This means you can be anywhere in or around the home and won't have to worry about being in the same room as the base station to communicate with outside help. We all know emergencies can happen in all parts of the home, so why settle for a PERS unit that only works when you are within short distance from the bases station. With the Home Security Store Medical Alert you can go about your daily life inside and outside the house up to several hundred feet away with no worry, knowing that help is only a push button away. Minimize

15% Off Site Wide. Ideal for Extricating Patients from Auto ... Read more

15% Off Site Wide. Ideal for Extricating Patients from Auto Accidents and Other Confined Spaces The Original Ferno K.E.D. is ideal for extricating and immobilizing patients from auto accidents and other confined spaces. The K.E.D. immobilizes the torso, head and neck, enabling prompt extrication while minimizing risks of further injury. X-rays or advanced life support procedures can be performed with the K.E.D. in place. Heavy-duty, vinyl-coated nylon is durable and easy to clean 33"L x 32"W (Open) Load limit: 500 lb; restraint weight: 8 lb Wraparound design provides horizontal flexibility for easy application and vertical rigidity for maximum support of the spine, neck, and head during extrication Immobilizes the torso, head and neck, enabling prompt extrication X-rays or advanced life support procedures can be performed with the K.E.D. in place Built-in handles enable rescuers to get a firm grip on the patient and K.E.D. as one unit Adapts to a hip and pelvic splint by simple inversion Adjustable, fold-back sides permit easy access to patient's chest Color-coded, sewn-in securing straps and snaplock buckles for quick, easy application Can be used for multiple patient sizes, including children and pregnant women Effective in immobilization of pediatric patients Ideal for immobilizing and extricating patients from auto accidents or confined spaces Does not interfere with the application of anti-shock trousers Includes wrap-around vest, Adjusta-Pad neck roll, two head straps and a carrying case Stores rolled up, ready for immediate use Minimize

The ScootaTrailer XL offers more than 700 extra square inch ... Read more

The ScootaTrailer XL offers more than 700 extra square inches of space so that you can carry the largest scooters and power wheelchairs, yet it still is compatible with vehicles like the Chevy Cavalier, Chrysler PT Cruiser, Ford Focus, Honda Accord, and Toyota Corolla. In fact, any vehicle with a class one trailer hitch is compatible with the ScootaTrailer XL because it only places 35 to 75 pounds of weight onto the hitch. What are the advantages of the ScootaTrailer XL and its universal design? Here are just a few: You don't need to buy a larger vehicle just to transport your scooter, power chair, or other mobility device. You can save gas by using a smaller vehicle. You can easily switch the ScootaTrailer XL from vehicle to vehicle because of the included Swivel Trailer Jack. The ramp height is very low, making loading easier than traditional vehicle lifts. An optional gas-strut makes it even easier to lower the ramp. You can still access the rear hatch of vans & SUVs or the rear trunk of cars. Traditional external lifts require you purchase a swing-away arm. Completely stable at highway speeds, it even has its own VIN number! With the optional lockable cover you get complete protection for your device and gas-strut assistance. Can be detached easily and rolled away into a carport or shed. Overall, the ScootaTrailer XL is the ideal solution for transporting scooters, power wheelchairs, and even small off-road vehicles. It offers safety, convenience, and tremendous compatibility. Minimize

With quiet, smooth operation and a heavy-duty steel frame, ... Read more

With quiet, smooth operation and a heavy-duty steel frame, this full electric bariatric bed from Drive Medical ensures you peaceful rest without skimping on strength and safety.The split-pan design with removable bed end is easily set-up without tools and offers a larger sleep surface than a conventional bed, one with a weight capacity of 1,000 pounds. The hand-control device allows for multiple bed positioning, but an emergency manual crank also comes standard. A low air loss/alternating pressure mattress is available but not included. Features: Included: Full Electric Bed, 54" Heavy Duty Foam Mattress, 2 pair "T" Rails Bed: All steel construction. Larger sleep surface than conventional bed. Split pan design with removable bed ends is easy to set-up. No tools necessary for set-up. Hand control (included) provides for multiple bed positioning for patients. Emergency manual crank included.   Mattress: Top cover: Unitek 11 Nylon. Bottom cover: Vinyl. Top layer: 2.5 lb density foam. Middle layer: 2.5 lb density foam. Base: 4 lb density foam. Weight Capacity: 1000 lbs.   Bed Rails: Attractive brown vein finish. Constructed of 1" steel. Ideal protection without confining the patient. Provides maximum protection when bed is elevated. For use with most manufacturer's beds.   Minimize

The intent of this book (MDDR, for short) is to present an ... Read more

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the MDDR Users Group on LinkedIn. Minimize

Code L0627 Approved The Lumbar Sacral Orthosis, sagittal/c ... Read more

Code L0627 Approved The Lumbar Sacral Orthosis, sagittal/coronal control with rigid anterior and posterior molded frame, extends from the sacrococcygeal junction to T-9 vertebra. Lateral strength is provided by the rigid lateral molded frame and it produces intracavitary pressure to reduce load on intervertebral discs. The patented mechanical advantage pulley system with padded anterior rigid anterior panel allows the patient to actively participate in their treatment protocol by producing intracavitary pressure to reduce load on the spine. The CYBER-MAX LSO is totally modular providing stability and abdominal support with ergonomically molded polyethylene posterior/lateral and anterior shells affords the practitioner complete customization and patient comfort and compliance. Replaceable plush breathable laminate foam liners for patient comfort. Indications: Lumbar mechanical back pain Spinal stenosis Trauma Spondylolisthesis Facet syndrome Post operative stabilization protocol followingLaminotomy, Foraminotomy, IDET procedures, AnteriorLaprorscopic fusion and Multilevel decompression Features and Benefits: Original patented mechanical advantage pulley system Interactive patient controlled lumbar and compression conformity Rigid ergonomic posterior panel Ergonomic plastic anterior panel Targeted segmental therapy effectiveness controlling undesirable motion Fitting Specifications: Size Circ. Item # S 30” – 35” CMAX-NB-1 M 35” – 40” CMAX-NB-2 L 40” – 45” CMAX-NB-3 XL 45”– 50” CMAX-NB-4 U.S. Patent No. RE35,940 Minimize

Design Controls for the Medical Device Industry provides re ... Read more

Design Controls for the Medical Device Industry provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations. It also offers product development models for the production of safe, durable, and cost-efficient medical devices and systems. The book details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. It presents blueprints for the application, evaluation, and refinement of quality assurance and performance practices, from product launch through engineering and assembly. Minimize

Store Search search Title, ISBN and Author Medical Devices ... Read more

Store Search search Title, ISBN and Author Medical Devices for Respiratory Dysfunction: Principles and Modeling of Continuous Positive Airway Pressure (Cpap) by Ahmed Al-Jumaily Estimated delivery 3-12 business days Format Hardcover Condition Brand New Details ISBN 0791859770 ISBN-13 9780791859773 Title Medical Devices for Respiratory Dysfunction: Principles and Modeling of Continuous Positive Airway Pressure (Cpap) Author Ahmed Al-Jumaily Format Hardcover Pages 248 Publisher American Society o Minimize

Bathmaster's Sonaris Bath Lift offers a complete package of ... Read more

Bathmaster's Sonaris Bath Lift offers a complete package of reliability and utility for users of bath mobility aids. Simply insert the battery and place the Sonaris Bathtub Lift in your tub, and it's ready for use. This bath tub lift is easy to break down and reassemble, making it an excellent option for users who need to take their bath lift with them on trips away from home. The hand control lets you raise and lower the lift and recline the backrest just by pressing a button. When fully charged, the battery will last for about 18 uses of the lift, and the Sonaris is equipped with an indicator light and warning tone that lets you know when you need to recharge your battery. This Sonaris Bathtub Lift comes with a 5-year warranty on the frame and a 2-year warranty on the hand control and recharger. Minimize

The UltraTENS combines the 2 most proven modalities for pai ... Read more

The UltraTENS combines the 2 most proven modalities for pain relief into one device: Deep heat from a 1 MHz ultrasound and TENS with 14 preset functions. This device is simple to operate. Both pain relieving modalities can be used simultaneously. Some of the potential uses and benefits of the UltraTENS include: Therapeutic Ultrasound 1. Pain relief 2. Reduction of muscle spasm 3. Joint contractures Transcutaneous Electrical Nerve Stimulation 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain Minimize

Medical Alarm Monitoring, for less than $1 per day you can ... Read more

Medical Alarm Monitoring, for less than $1 per day you can be assured that you will always be connected to highly trained specialists who respond immediately in a friendly, calm manner and stay with you until help arrives. Comparing medical alarm companies can be hard. There are a lot of companies that claim to be offering a similar service. For a decision this important it is critical to make sure that you have all of the necessary information. Minimize

This reference provides real-world examples, strategies, an ... Read more

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems.Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit.Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditionsPresenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines. Minimize

BRAND NEW BP MEDICAL TRACTION DEVICE AMBULANCE SPLINT Our T ... Read more

BRAND NEW BP MEDICAL TRACTION DEVICE AMBULANCE SPLINT Our Traction Device stores in a 9 1/2"L x 3 1/2?"W and weighs under 20 oz. You can now carry your traction device in a trauma box, or first aid kit. The traction pole length quickly adjusts for adult or pediatric application. The need for patient roll-over or unnecessary leg raising has been eliminated. There is no ischial bar, so all problems of needless pressure are a thing of the past. Antishock pants can be quickly and easily applied ove Minimize