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 Wheelchair

WC-2:2009

Standard Organization: ANSI RESNA

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

Recognition NumberPhysical Medicine
Recognition Date2018-09-17
Recognition List050
Recognition Number16-185
Extent Complete standard
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STG Physical Medicine
FDA Tech  John Marszalek   FDA/OMPT/CDRH/OC/DICO/FEB/   301-796-7067   john.marszalek@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies

Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995.

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