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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 16-176
ANSI RESNA WC-2:2009 Section 9 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic Tests for Electrically Powered Wheelchairs
This section of RESNA WC-2 specifies requirements and test methods to determine the effects of rain and condensation and the effects of changes of temperature on the basic functioning of electrically powered wheelchairs, including scooters, intended to carry one person, with a maximum speed not exceeding 15 km/h. This section of RESNA WC-2 does not include requirements for resistance to corrosion.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of RESNA WC-2:2009 Section 9 [Rec# 16-176] will be superseded by recognition of RESNA WC-2:2019 Section 9 [Rec# 16-215]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-176] until December 25, 2020. After this transition period, declarations of conformity to [Rec# 16-176] 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.