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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 16-176
Standard
ANSI RESNA WC-2:2009 Section 9: Climatic Tests for Electrically Powered Wheelchairs
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic Tests for Electrically 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
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 John Marszalek
  FDA/OMPT/CDRH/OC/DICO/FEB/
  301-796-7067
  john.marszalek@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
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