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Recognized Consensus Standards

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FR Publication Date: 01/30/2014 

Part B: Supplementary Information

ANSI / RESNA WC/Volume 1 - 1998, section 11: wheelchairs - test dummies. (Physical Medicine)
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:
Mechanical Wheelchairs, 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.

Standard specifies the construction of test dummies with nominal masses of 25 kg, 50 kg, 75 kg, and 100 kg. The test dummies are so designed that their centers of gravity with respect to a wheelchair are located at approximately the same positions as those of an average human being of the same mass seated in a wheelchair. Any test dummies that are designed to test wheelchairs with maximum capacities greater than 100 kg should follow the principles listed in this standard.
Related CFR Citations and Product Codes:
Device Name Device
§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 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
FDA Technical Contact:
 Laurence Coyne
  10903 New Hampshire Avenue Building 66, Room 1526
  Silver Spring MD 20993
  email: laurence.coyne@fda.hhs.gov