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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 034 Date of Recognition 01/30/2014 
FR Recognition Number 16-166
Standard
ISO 7176-21 Second edition 2009-04-01
Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
Scope/Abstract
ISO 7176-21:2009 specifies requirements and test methods for electromagnetic emissions and for electromagnetic immunity of electrically powered wheelchairs and scooters with a maximum speed of not more than 15 km/h intended for indoor and/or outdoor use by people with disabilities. It is also applicable to manual wheelchairs with an add-on power kit. It is not applicable to vehicles designed to carry more than one person.

ISO 7176-21:2009 also specifies requirements and test methods for the electromagnetic compatibility of battery chargers intended for use with electrically powered wheelchairs and scooters.

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 Wheelchair, Mechanical Class 1 IOR
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 John Marszalek
  FDA/OMPT/CDRH/OC/DICO/FEB/
  301-796-7067
  john.marszalek@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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