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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 054 Date of Entry 07/06/2020 
FR Recognition Number 16-170
ANSI RESNA WC-1:2009 Section 3 American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes
Scope/Abstract
This section of RESNA WC-1 specifies test methods for the measurement of the effectiveness of brakes of manual wheelchairs and powered wheelchairs, including scooters, intended to carry one person, with a maximum speed not exceeding 15 km/h. It also specifies disclosure requirements for the manufacturer.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of RESNA WC-1:2009 Section 3 [Rec# 16-170] will be superseded by recognition of RESNA WC-1:2019 Section 3 [Rec# 16-209]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 16-170] until December 25, 2020. After this transition period, declarations of conformity to [Rec # 16-170] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3800 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
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3850 Stroller, Adaptive Class 1 LBE
FDA Technical Contact
 Angela DeMarco
  FDA/OC/CDRH/OPEQ/ORP/DRPI/
  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
*These are provided as examples and others may be applicable.
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