Recognized Consensus Standards

Recognition List Number: 029 Publication Date: 08/20/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 16-189: ASME A18.1-2011 (Revision of ASME A18.1-2008), Safety Standard for Platform Lifts and Stairway Chairlifts. (Physical Medicine)

Date of Standard: 2011. 

Address of Standards Organization:

  American Society of Mechanical Engineers (ASME)

  345 East 47th Street

  New York, NY 10017-2392

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Wheelchair Elevators; and may affect: Mechanical wheelchairs, Powered wheelchairs, Motorized three-wheeled vehicles, Special grade wheelchairs, or Standup Wheelchairs

Processes Affected:

510(k), IDE, PMA, PDP, Design Controls

Type of Standard:

 Vertical, National

Extent of Recognition:

Complete standard

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

Relevant Guidance:

There is no relevant guidance developed at this time.

FDA Technical Contact:

  Laurence Coyne

  FDA/CDRH/ODE

  10903 New Hampshire Avenue Building 66, Room 1526

  Silver Spring MD 20993

  301/796-5650

  Email: laurence.coyne@fda.hhs.gov