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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 041 Date of Entry 04/04/2016 
FR Recognition Number 16-196
Standard
ISO  7176-7 First Edition 1998-05-15
Wheelchairs - Part 7: Measurement of seating and wheel dimensions
Scope/Abstract
This part of ISO 7176 specifies a method for measuring the seating and wheel dimensions of wheelchairs.

It is applicable to wheelchairs and vehicles intended to provide indoor and outdoor mobility at speed up to 15 km/h for people with disabilities whose mass does not exceed 120 kg, including the following classifications from ISO 9999:1992:

Electric motor-driven wheelchairs with manual steering 12 21 24
Electric motor-driven wheelchairs with power steering 12 21 27
Powered attendant-controlled wheelchairs 12 21 21
Manual attendant-controlled wheelchairs 12 21 03
Bimanual rear-wheel-driven wheelchairs 12 21 06
Bimanual front-wheel-driven wheelchairs 12 21 09
Bimanual lever-driven wheelchairs 12 21 12
Single-side-driven nonpowered wheelchairs driven by one arm or one leg 12 21 15
Foot-propelled wheelchairs 12 21 18
It does not apply to wheelchairs with a seat width of less than 212 mm.

This part of ISO 7176 does not specify nominal seating and wheel dimensions for wheelchairs.
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*
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995.

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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