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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 16-229
Standard
RESNA ANSI  WC-4:2017 Section 20
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles
Scope/Abstract
For many people with mobility-related disabilities who must remain seated in their wheelchairs when traveling in motor vehicles, their wheelchair must serve as the vehicle seat and therefore becomes an important part of the occupant-protection system. In these situations, wheelchairs must provide stable and effective support for their occupants during normal vehicle operation, emergency vehicle maneuvers, and crash conditions. Providing effective occupant support during crash conditions is especially important for maintaining proper positioning of the lap-belt restraint over the occupant's bony pelvis during impact loading, thereby reducing the likelihood of the occupant "submarining" under the pelvic belt, which can result in injuries to the abdomen and spine from lap-belt loading. Wheelchair frames and seating systems that are not designed to withstand crash forces place their occupants at increased risk of serious injuries in vehicle crashes.

Section 20 defines requirements for wheelchairs, including their seating systems, which are intended for use as motor vehicle seats. However, seating systems are often provided as after-market products, independent of a wheelchair frame and the same seating system may be adapted to more than one wheelchair frame. Therefore, requirements must be defined for seating systems alone, independent of a specific wheelchair frame. Such requirements are defined in WC20.
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 Mechanical wheelchair.
§890.3860 Powered wheelchair.
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Stair-climbing wheelchair.
§890.3900 Standup wheelchair.
§890.3910 Restraint, Wheelchair, Non-Protective Class 1 KID
§890.3910 Accessories, Wheelchair Class 1 KNO
§890.3920 Components, Wheelchair Class 1 KNN
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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