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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 16-195
Standard
ISO  7176-1 Third edition 2014-10-01
Wheelchairs - Part 1: Determination of static stability
Scope/Abstract
ISO 7176-1:2014 specifies test methods for determining the static stability of wheelchairs. It is applicable to manual and electrically powered wheelchairs, including scooters, with a maximum speed not greater than 15 km/h, intended to provide indoor and/or outdoor mobility for one disabled person whose mass is within the range represented by ISO 7176-11.

For active stability-controlled wheelchairs, ISO 7176-1:2014 applies to the device in a stable, parked state.

ISO 7176-1:2014 provides a method for the measurement of the tipping angles (either wheelchair tipping angle or anti-tip device tipping angle), but this method is not applicable to wheelchairs with lateral anti-tip devices and does not consider sliding on the ground.

ISO 7176-1:2014 also includes requirements for test reports and information disclosure.
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
 Angela DeMarco
  FDA/OC/CDRH/OPEQ/ORP/DRPI/
  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
*These are provided as examples and others may be applicable.
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