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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR 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 Development 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
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Wheelchair, Stair Climbing Class 3 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
§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
  email: laurence.coyne@fda.hhs.gov
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