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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 16-175
Standard
ANSI RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
Scope/Abstract
This section of RESNA WC-1 specifies requirements for static, impact and fatigue strength of wheelchairs including scooters intended for users whose mass does not exceed 100 kg. It specifies

the test methods for determining whether the requirements have been met. It also specifies requirements for disclosure of the test results. The test methods may also be used to verify manufacturers' claims that a product exceeds the minimum requirements of this section of RESNA WC-1. A reference configuration is specified for adjustable wheelchairs and scooters to enable test results

to be used for the comparison of performance.

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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