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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 Entry 01/30/2014 
FR Recognition Number 16-179
ANSI RESNA WC-1:2009 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
Transition Period
FDA recognition of RESNA WC-1:2009 Section 13 [Rec# 16-179] will be superseded by recognition of RESNA WC-1:2019 Section 13 [Rec# 16-218]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-179] until December 25, 2020. After this transition period, declarations of conformity to [Rec# 16-179] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§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
FDA Technical Contact
 Kathryn Delaurentis
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  240-402-4911
  kathryn.delaurentis@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
*These are provided as examples and others may be applicable.
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