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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 2 - 1998, section 9: climatic tests for electric wheelchairs. (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:
OFFICE OF DEVICE EVALUATION (ODE)
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.

Standard specifies requirements and test methods to determine the effects of rain and condensation and the effects of changes of temperature on the basic functioning of electrically powered wheelchairs including scooters.
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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