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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 16-226
Standard
RESNA ANSI  WC-4:2017 Section 10
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transporation Section 10 Wheelchair and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers.
Scope/Abstract
Section 10 applies to wheelchair passenger spaces intended for use by rear-facing wheelchair-seated occupants with a body mass greater than 22 kg, when traveling in accessible transport vehicles. It applies to RF-WPSs for use in LATVs used mainly on fixed route services when operated under normal and emergency driving conditions, where passengers are allowed to travel both sitting and standing. For the purposes of WC10 the term wheelchair includes scooters with three and more wheels.

WC10 specifies design and performance requirements and associated test methods, requirements for manufacturer instructions and warnings to installers and users, as well as requirements for product labeling, and disclosure of test information.

The primary purpose of WC10 is to ensure adequate clearance space for wheelchair access, provide head and back support for the wheelchair occupant, and limit those movements of a rear-facing wheelchair that can result in hazardous occupant contact with the vehicle interior or injury to other passengers.

The provisions of WC10 apply primarily to a complete RF-WPS, but subsets of the provisions can be applied to components and subassemblies sold separately, as appropriate to the specific functions of the components and/or subassemblies they are intended to replace.
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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