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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
Standard
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
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
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
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  240-402-4911
  kathryn.delaurentis@fda.hhs.gov
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.
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