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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 16-218
Standard
RESNA ANSI  WC-1:2019 Section 13
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of Coefficient of Friction of Test Surfaces
Scope/Abstract
This section of RESNA WC-1 specifies a test method for determining the coefficient of friction of a test surface that has a rough texture, such as unfinished concrete. In the event that the test method is used for smooth or polished surfaces, care should be exercised that the coefficient of friction is measured as being constant over the whole area of the test surface. Several test procedures for wheelchairs, e.g., those specified in RESNA WC-1 Sec. 1, RESNA WC-2 Sec. 2, RESNA WC-2 Sec. 3, RESNA WC-2 Sec. 6 and RESNA WC-2 Sec. 10, require that
the coefficient of friction of the test surface be within specified limits.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3850 Stroller, Adaptive Class 1 LBE
§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 FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Kathryn Delaurentis
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  240-402-4911
  kathryn.delaurentis@fda.hhs.gov
Standards Development Organizations
RESNA Rehabilitation Engineering and Assistive Technology Society of North America http://www.resna.org/
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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