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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 16-221
Standard
RESNA ANSI  WC-1:2019 Section 16
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods
Scope/Abstract
This section of RESNA WC-1 specifies requirements and methods to assess the resistance to ignition by cigarette and match of the materials used in wheelchair upholstered parts. The tests measure only the resistance to ignition by cigarette and match of the materials tested and not the ignitability of the finished wheelchair. They give an indication of, but cannot guarantee, the ignition behavior of the finished wheelchair.
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
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3850 Stroller, Adaptive Class 1 LBE
§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
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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