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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 16-183
ANSI RESNA WC-1:2009 Section 20 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs
Scope/Abstract
This section of RESNA WC-1 specifies test methods and requirements for determining the safety and performance of manual and powered wheelchairs that have a mode to assist the occupant

to/and support the occupant while in the stand-up position. Included are wheelchairs that are stationary and those that are mobile while in the stand-up mode.

This section of RESNA WC-1 is an addition to existing wheelchair standards, which apply to standup type wheelchairs when they are configured for the sit-down mode. Before testing a stand-up wheelchair in the stand-up configuration in accordance with this section of RESNA WC-1, the wheelchair shall first be tested in the sit-down configuration in accordance with the existing RESNA

WC-1 wheelchair standards with modifications that are noted in this section of RESNA WC-1.

Extent of Recognition
Complete standard
Transition Period
FDA recognition of RESNA WC-1:2009 Section 20 [Rec# 16-183] will be superseded by recognition of RESNA WC-1:2019 Section 20 [Rec# 16-222]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-183] until December 25, 2020. After this transition period, declarations of conformity to [Rec# 16-183] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3900 Wheelchair, Standup Class 2 IPL
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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