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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 16-171: ANSI / RESNA WC-2:2009, section 4: energy consumption of electrically powered wheelchairs and scooters for determination of theoretical dis. (Physical Medicine)

Date of Standard: 2009. 
Addresses of Standards Development 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:
Devices Affected:
Powered Wheelchairs and Motorized 3-Wheeled Vehicles (Scooters)
Processes Affected:
510(K), IDE, PMA, PDP, Design Controls
Type of Standard:
 Test Methods, National, Vertical
Extent of Recognition:
Complete Standard and any annexes.
Related CFR Citations and Product Codes:
Device Name Device
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
FDA Technical Contact:
 John Marszalek
  10903 New Hampshire Avenue Building 66, Room 1427
  Silver Spring MD 20993
  email: john.marszalek@fda.hhs.gov