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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 16-227
Standard
RESNA  WC-4:2017 Section 18
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles.
Scope/Abstract
This standard applies to WTORS comprised of a system or device for securing or tying down wheelchairs, including three- and four-wheeled scooter wheelchairs, and a system of belts for restraining occupants seated in wheelchairs. It applies to complete WTORS in which all components are provided by the WTORS manufacturer, but it also applies to WTORS that are completed by using portions of belt-restraint systems provided by the vehicle manufacturer (i.e., OEM belt restraints), particularly for people who drive while seated in their wheelchair.


WC18 applies to WTORS designed for use with a wide range of wheelchairs and their occupants, as well as to WTORS designed for limited use with a specific wheelchair model and/or occupant range. It applies only to WTORS intended for use with forward-facing wheelchair-seated children and adults with a body mass of 12 kg (26.5 lb) or more who are traveling as passengers or drivers in private, paratransit, public, and school vehicles. It applies to WTORS that use all types of wheelchair tiedown and securement methods, but it only applies to WTORS that include both upper- and lower-torso belt-type occupant restraints.
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 Organization
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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