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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 034 Date of Entry 01/30/2014 
FR Recognition Number 16-163
Standard
ISO  7176-5 Second edition 2008-06-01
Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
Scope/Abstract
ISO 7176-5:2007 specifies methods for the determination of wheelchair dimensions and mass.

This includes specific methods for the determination of outside dimensions when the wheelchair is occupied by a reference occupant and the required manoeuvring space needed for wheelchair manoeuvres commonly carried out in daily life.

ISO 7176-5:2007 specifies requirements for the disclosure of the dimensions and masses and contains five informative annexes.

Annex A specifies methods for the determination of technical dimensions that can be important to the performance of the wheelchair.

Annex B provides detailed information about pivot width and reversing width.

Annex C provides detailed information about the turning diameter.

Annex D provides details on determining the wheelchair longitudinal axis and wheelchair centre-point.

Annex E provides technical guidelines and interpretation for many of the measurements specified to facilitate improved understanding, design and construction of wheelchairs.

ISO 7176-5:2007 is applicable to manual wheelchairs and electrically powered wheelchairs (including scooters).
Extent of Recognition
Complete standard
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 Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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