Recognized Consensus Standards

Recognition List Number: 023 Publication Date: 05/05/2010

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 16-164: ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs. (Physical Medicine)

Date of Standard: 2008.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Mechanical and Electrical Wheelchairs

Processes Affected:

510(k), IDE, PMA, PDP

Type of Standard:

International, Vertical, Test Methods

Extent of Recognition:

Complete Standard.

Standard covers functional dimensions and test method considerations for the characterization and comparison of mechanical and powered wheelchairs. Additional information must be provided to document that the design of the product will provide adequate mechanical and electrical properties for the particular application.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§890.3800	Vehicle, Motorized 3-Wheeled	Class 2	INI

Regulation Number	Device Name	Device Class	Product Code
§890.3850	Wheelchair, Mechanical	Class 1	IOR

Regulation Number	Device Name	Device Class	Product Code
§890.3860	Wheelchair, Powered	Class 2	ITI

Regulation Number	Device Name	Device Class	Product Code
§890.3880	Wheelchair, Special Grade	Class 2	IQC

Regulation Number	Device Name	Device Class	Product Code
§890.3890	Wheelchair, Stair Climbing	Class 3	IMK

Regulation Number	Device Name	Device Class	Product Code
§890.3900	Wheelchair, Standup	Class 2	IPL

Regulation Number	Device Name	Device Class	Product Code
§890.3930	Elevator, Wheelchair, Portable	Class 2	ING