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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 16-167
Standard
ISO 7176-9: Third edition 2009-11-15
Wheelchairs - Part 9: Climatic tests for electric wheelchairs
Scope/Abstract
ISO 7176-9:2009 specifies requirements and test methods to determine the effects of rain, dust, 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.

ISO 7176-9:2009 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
§890.3850 Wheelchair, Mechanical Class 1 IOR
§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 Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
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