fda standards 2017-04-05T19:15:42+00:00

FDA Registered Carpal Tunnel Treatment – Carpal Solution

The elastic soft foam core center component has been specially engineered from a confidential combination of medical grade closed-cell polyvinyl chloride foam and polyurethane adhesive film to achieve the optimum balance of comfort, elastic tension, structural strength, ergonomics, hypoallergenicity and cost performance.The Carpal Solution has been designed for proactive discriminating healthcare consumers. It is constructed of carefully selected hypoallergenic materials and is manufactured in an FDA Drug & Device registered facility. The Carpal Solution is manufactured in compliance with FDA standards for medical device manufacturing with quality systems that are ISO9002:1994 and 13488:1996 certified. The materials of construction are as follows:

Medical grade ethylene vinyl acetate (EVA) adhesive wrist-straps and thumb strap are attached to the elastic soft foam core center through a unique process designed to achieve the appropriate strength and ergonomic comfort. The Carpal Solution employs the same adhesive used in hospitals to secure IV’s and tubing to patient’s skin before, during, and under post surgical care. It is tested to the highest standards of the US Food and Drug Administration (FDA).

The ethylene vinyl acetate straps are carefully perforated, to serve several important functions. First to allow the Carpal Solution to be easily custom fit to each user’s unique hand size and shape with minimal effort and no extra equipment. It is a key part of the easy three-step self application that makes the Carpal Solution readily usable by millions as a reliable self-treatment device to eliminate the symptoms of Carpal Tunnel Syndrome. The perforation also enhances breath-ability of the polyethylene straps for user comfort during the 6 to 8 hours of sleep. The tear-away straps also limit the amount of tension that can be applied with a built in burst-strength safety feature.

All straps are supplied with a paper liner on the underside to protect the hypoallergenic adhesive backing until it is ready to be self-applied.

The Carpal Solution packaging is done according to FDA Class 1 standards.

All material components have been tested in accordance with the ISO 10993 Part-1 “Biological Evaluation of Medical Devices”, as put forth by the FDA. All components have satisfied the standard testing requirements for devices in contact with skin for short term applications (up to 29 days). All laboratory testing was conducted in accordance with the FDA Good Laboratory Practices Regulation of 1978. All components are made from clinically documented hypoallergenic materials and are generally recognized as non-sensitizing to the general public. FDA Registration of Device Establishment No: 3,005,223,380.

It is rare for anyone to experience skin sensitivity issues when using the Carpal Solution. However, if any skin allergy develops from any cause, discontinue use and see a physician. Please read and follow the user-friendly application instructions and diagrams inside each package before use.

Not intended for use – The Carpal Solution should not be used: in the vicinity of open wounds, if an allergic reaction occurs, in conjunction with any skin disorder, where bone tissue deformity is present. Do not use to relieve symptoms caused by Auto Immune Disorders, Arthritis, Diabetes, Gout, Hypothyroidism, Menopause, Wrist Fractures and Dislocations.

First Hand Medical’s active product stewardship program demands high standards of excellence. Please let us know of any quality issues at one of the contact options below:

US FDA Registered