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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 16-168
ANSI RESNA WC-1:2009 Section 1 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1 Determination of static stability
Scope/Abstract
This section of RESNA WC-1 specifies the test methods for determining the static tipping stability of wheelchairs, including scooters. This section of RESNA WC-1 is applicable to wheelchairs and

vehicles that are included in the 12.21 series described in ISO 9999 and are intended to provide indoor and outdoor mobility for people with disabilities whose mass does not exceed the maximum

mass of the test dummy given in ISO 7176-11.

Extent of Recognition
Complete standard
Transition Period
FDA recognition of RESNA WC-1:2009 Section 1 [Rec# 16-168] will be superseded by recognition of RESNA WC-1:2019 Section 1 [Rec# 16-207]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 16-168] until December 25, 2020. After this transition period, declarations of conformity to [Rec # 16-168] 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
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3850 Wheelchair, Mechanical Class 1 IOR
§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
 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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