Recognized Consensus Standards

Part B: SUPPLEMENTARY INFORMATION

ANSI / RESNA , . ()

Addresses of Standards Organizations:

American National Standards Institute (ANSI)

25 West 43rd Street

4th Floor

New York, NY 10036

Rehabilitation Engineering and Assistive Technology Society of North America (RESNA)

1700 N. Moore Street

Suite 1540

Arlington, VA 22209-1903

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Processes Affected:

Type of Standard:

Test Methods, National, Vertical

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

FDA Technical Contact:

Laurence Coyne

FDA/CDRH/ODE

10903 New Hampshire Avenue Building 66, Room 1526

Silver Spring MD 20993

301/796-5650