• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 16-228
ANSI RESNA WC-4:2017 Section 19 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles.
Scope/Abstract
Section 19 specifies general design requirements, test procedures, and performance requirements for complete wheelchairs that can be considered to offer suitable and safe forward-facing seating for passengers traveling in transit, paratransit, school bus, over-the-road coaches, and personally licensed vehicles. The standard applies to the securement of wheelchairs by four-point strap-type tiedown systems that are occupied by child- and adult-d passengers restrained by belt-type occupant restraints. The standard applies to a wide range of wheelchair types and styles, including manual wheelchairs, powerbase wheelchairs, three-wheeled scooters, tilt-in-space wheelchairs, and specialized mobile seating bases with removable seating inserts. It applies primarily to wheelchairs as purchased from the OEM manufacturer, but also has application to wheelchairs that are retrofitted for use as a motor-vehicle seat by the addition of after-market add-on components.

The standard places particular emphasis on design requirements, test procedures, and performance criteria related to frontal impact performance. However, it also includes design and performance requirements for wheelchairs with regard to accessibility to motor-vehicles and stability during normal vehicle travel. The standard specifies strength and geometric requirements for wheelchair securement points and occupant restraint anchorage points on the wheelchair. It also provides requirements and information for wheelchair accessory components, seat inserts, and postural support devices with regard to their design and use in motor vehicles.

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
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3910 Accessories, Wheelchair Class 1 KNO
§890.3910 Restraint, Wheelchair, Non-Protective Class 1 KID
§890.3920 Components, Wheelchair Class 1 KNN
§890.3860 Wheelchair, Powered Class 2 ITI
Relevant FDA Guidance and/or Supportive Publications*
There is no published relevant guidance at this time.
FDA Technical Contact
 Kathryn Delaurentis
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  240-402-4911
  kathryn.delaurentis@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
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.
-
-