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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 16-185
Standard
ANSI RESNA WC-2:2009
American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters
Scope/Abstract
This section of RESNA WC-2 specifies requirements and test methods for electromagneticemissions and for electromagnetic immunity of electrically powered wheelchairs and motorizedscooters for indoor and outdoor use by people with disabilities. It is also applicable to manualwheelchairs with an add-on power kit. It is not applicable to vehicles designed to carry more thanone person.This section of RESNA WC-2 also specifies electromagnetic compatibility requirements and testmethods for battery chargers intended for use with electrically powered wheelchairs and scooters.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies
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
§890.3800 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
 John Marszalek
  FDA/OMPT/CDRH/OC/DICO/FEB/
  301-796-7067
  john.marszalek@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
RESNA Rehabilitation Engineering and Assistive Technology Society of North America http://www.resna.org/
FDA Specialty Task Group (STG)
Physical Medicine
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