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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 034 Date of Entry 01/30/2014 
FR Recognition Number 16-162
Standard
ISO  7176-4 Third edition 2008-10-01
Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
Scope/Abstract
ISO 7176-4:2008 specifies methods for determining theoretical distance range of electrically powered wheelchairs, including scooters, using measurements of energy consumed while driving and the nominal energy capacity of the wheelchair's battery set. It is applicable to electrically powered wheelchairs with a maximum nominal speed no 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. ISO 7176-4:2008 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
§890.3860 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*
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
 Amir Razjouyan
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB
  301-796-2701
  Amir.Razjouyan@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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