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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 16-198
Standard
ISO 7176-22 Second edition 2014-09-01
Wheelchairs - Part 22: Set-up procedures
Scope/Abstract
ISO 7176-22:2014 specifies a set-up procedure to be used as a part of the preparation of adjustable wheelchairs for testing. This procedure takes the manufacturer's instructions into account.

ISO 7176-22:2014 is applicable to manual wheelchairs and electric wheelchairs (including scooters) intended to provide indoor and/or outdoor mobility.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3850 Stroller, Adaptive Class 1 LBE
Regulation Number Device Name Device Class Product Code
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
Regulation Number Device Name Device Class Product Code
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3850 Wheelchair, Mechanical Class 1 IOR
Regulation Number Device Name Device Class Product Code
§890.3860 Wheelchair, Powered Class 2 ITI
Regulation Number Device Name Device Class Product Code
§890.3880 Wheelchair, Special Grade Class 2 IQC
Regulation Number Device Name Device Class Product Code
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
Regulation Number Device Name Device Class Product Code
§890.3900 Wheelchair, Standup Class 2 IPL
Regulation Number Device Name Device Class Product Code
§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.
FDA Technical Contacts
 Angela DeMarco
  FDA/OC/CDRH/OPEQ/ORP/DRPI/
  301-796-4471
  Angela.Demarco@fda.hhs.gov
 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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