FDA Regulation and Registration of Wheelchair

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Class

Regulation Name

Regulation No.

A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, hand rim, hill holder, leg rest, heel loops, and toe loops.

Required

These manufacturers are required to register their establishment.

FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996.

KIC

Class

Regulation Name

Regulation No.

A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.

Required

These manufacturers are required to register their establishment.

FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996.