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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 Entry 01/30/2014 
FR Recognition Number 16-171
Standard
ANSI RESNA WC-2:2009 Section 4 American National Standard for Wheelchairs - Volume 2 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy Consumption of Electrically Powered Wheelchairs and Scooters for Determination of Theoretical Distance Range
Scope/Abstract
This section of RESNA WC-2 specifies a method for determining the theoretical distance range of electrically powered wheelchairs and scooters from a measurement of energy consumed over a specified distance and the nominal energy capacity of the wheelchair's battery set. It is applicable to electrically powered wheelchairs and scooters with a maximum speed not greater than 15 km/h, intended to provide indoor and/or outdoor mobility for one disabled person with a disability whose mass is within the range represented by RESNA WC-1 Sec. 11. This document also includes requirements for test reports and information disclosure.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of RESNA WC-2:2009 Section 4 [Rec# 16-171] will be superseded by recognition of RESNA WC-2:2019 Section 4 [Rec# 16-210]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 16-171] until December 25, 2020. After this transition period, declarations of conformity to [Rec # 16-171] will not be accepted.
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
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§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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