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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 16-183: ANSI / RESNA WC-1:2009, american national standard for wheelchairs - volume 1: requirements and test methods for wheelchairs (including scooters) section 20: determination of the performance of stand-up type wheelchairs. (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:
Mechanical Stand-up Wheelchairs and Powered Stand-up Wheelchairs
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
§890.3900 Wheelchair, Standup Class 2 IPL
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
 John Marszalek
  10903 New Hampshire Avenue WO66 RM3661
  Silver Spring MD 20993
  email: john.marszalek@fda.hhs.gov