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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 16-222
RESNA ANSI  WC-1:2019 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
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
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3900 Wheelchair, Standup Class 2 IPL
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Kathryn Delaurentis
Standards Development Organizations
RESNA Rehabilitation Engineering and Assistive Technology Society of North America http://www.resna.org/
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.