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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 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
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Kathryn Delaurentis
  FDA/OMPT/CDRH/ODE/DNPMD/PMDB/
  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
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