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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 16-215
Standard
ANSI RESNA WC-2:2019 Section 9 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs
Scope/Abstract
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
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FDA recognition of RESNA WC-2:2009 Section 9 [Rec# 16-176] will be superseded by recognition of RESNA WC-2:2019 Section 9 [Rec# 16-215].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.
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