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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Recognition 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
§890.3930 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
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995.
FDA Technical Contact
 Angela DeMarco
  FDA/OMPT/CDRH/ODE/POS/510(K)/
  301-796-4471
  angela.demarco@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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