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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 16-159: ISO 7176-2 Second edition 2001-06-15, wheelchairs - part 2: determination of dynamic stability of electric wheelchairs. (Physical Medicine)

Date of Standard: 2001. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Mechanical and Powered Wheelchairs
Processes Affected:
510(k), IDE, PMA, PDP
Type of Standard:
 Test Methods, International, Vertical
Extent of Recognition:
Complete Standard.

Standard covers functional dimensions and test method considerations for the characterization and comparison of mechanical and powered wheelchairs. Additional information must be provided to document that the design of the product will provide adequate mechanical and electrical properties for the particular application.
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
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
 Angela DeMarco
  10903 New Hampshire Avenue WO66 RM2624
  Silver Spring MD 20993
  email: angela.demarco@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036