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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 16-184
Standard
ANSI RESNA WC-1:2009 Section 22: Set-up Procedures
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures
Scope/Abstract
This section of RESNA WC-1 specifies a set-up procedure to be used in the preparation of adjustable wheelchairs for testing in accordance with the RESNA WC series. This procedure gives

methods to be used where there are no manufacturer's instructions for setting the wheelchair adjustments.This section of RESNA WC-1 is applicable to manual wheelchairs and electric wheelchairs

(including scooters) intended to provide indoor and/or outdoor mobility. Other sections of RESNA WC-1 may give specific requirements for the adjustment of thewheelchair. In such cases, that individual section of RESNA WC-1 takes precedence over this section of RESNA WC-1.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Angela DeMarco
  FDA/OMPT/CDRH/ODE/POS/510(K)/
  301-796-4471
  angela.demarco@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
RESNA Rehabilitation Engineering and Assistive Technology Society of North America http://www.resna.org/
FDA Specialty Task Group (STG)
Physical Medicine
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