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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 16-212
Standard
ANSI RESNA WC-2:2019 Section 6 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs.
Scope/Abstract
This section of RESNA WC-2 specifies test methods for determining the maximum speed, acceleration and deceleration of electrically powered wheelchairs, including scooters, intended to carry one person, with a maximum nominal speed not exceeding 15 km/h (4,167 m/s).
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FDA recognition of RESNA WC-2:2009 Section 6 [Rec# 16-173] will be superseded by recognition of RESNA WC-2:2019 Section 6 [Rec# 16-212]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 16-173] until December 25, 2020. After this transition period, declarations of conformity to [Rec # 16-173] 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
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
FDA Technical Contact
 Angela DeMarco
  FDA/OC/CDRH/OPEQ/ORP/DRPI/
  301-796-4471
  angela.demarco@fda.hhs.gov
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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