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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Recognition 04/04/2016 
FR Recognition Number 16-195
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
§890.3930 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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