FDA Registration of Wheelchair

Most appropriate code is KNN and it is 510(k) exempted devices.

 

 
 

 

 

 

 

 

 


KNN

 

 

 

 

 

 

Device NameComponents, Wheelchair
 

Class

 

1
 

Regulation Name

 

Wheelchair component.
 

Regulation No.

 

890.3920
Identification 

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.

 

Submission Type510(k) exempts
GMP Exempt? 

Required

 

Remarks 

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

 

 

 

 

 

 

Device NameCushion, Flotation
 

Class

 

1
 

Regulation Name

 

Flotation cushion.
 

Regulation No.

 

890.3175
Identification 

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.

Submission Type510(k) exempts
GMP Exempt? 

Required

 

Remarks 

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.