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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 16-184
ANSI RESNA WC-1:2009 Section 22 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures
This section of RESNA WC-1 specifies a set-up procedure to be used in the preparation of adjustable wheelchairs for testing in accordance with the RESNA WC series. This procedure gives

methods to be used where there are no manufacturer's instructions for setting the wheelchair adjustments.This section of RESNA WC-1 is applicable to manual wheelchairs and electric wheelchairs

(including scooters) intended to provide indoor and/or outdoor mobility. Other sections of RESNA WC-1 may give specific requirements for the adjustment of thewheelchair. In such cases, that individual section of RESNA WC-1 takes precedence over this section of RESNA WC-1.

Extent of Recognition
Complete standard
Transition Period
FDA recognition of RESNA WC-1:2009 Section 22 [Rec# 16-184] will be superseded by recognition of RESNA WC-1:2019 Section 22 [Rec# 16-223]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-184] until December 25, 2020. After this transition period, declarations of conformity to [Rec# 16-184] will not be accepted.
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 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
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
FDA Technical Contact
 Angela DeMarco
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.