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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 053 Date of Entry 12/23/2019 
FR Recognition Number 16-219
Standard
ANSI RESNA WC-2:2019 Section 14 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods
Scope/Abstract
This section of RESNA WC-2 specifies the requirements for the power and control systems of electrically powered wheelchairs, including battery chargers, and associated test methods. It sets minimum requirements for the protection of the wheelchair user during normal use and some conditions of abuse and failure. It also specifies methods of measurement of the forces necessary to operate the controls and sets limits on the forces needed for some operations. This section of RESNA WC-2 is applicable to electrically powered vehicles intended to provide indoor and outdoor mobility for disabled persons whose mass at speeds up to 15 km/h does not exceed 100 kg. It is not applicable to electrically powered vehicles which incorporate devices that need to be connected to a domestic or industrial power supply greater than 100 volts (e.g., those with built-in battery chargers). It does not include requirements on electromagnetic susceptibility or emissions.
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.
Transition Period
FDA recognition of RESNA WC-2:2009 Section 14 [Rec# 16-180] will be superseded by recognition of RESNA WC-2:2019 Section 14 [Rec# 16-219]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-180] until December 25, 2020. After this transition period, declarations of conformity to [Rec# 16-180] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§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
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
*These are provided as examples and others may be applicable.
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