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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 16-164
Standard
ISO 7176-10 Second edition 2008-11-01
Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
Scope/Abstract
ISO 7176-10:2008 specifies test methods for determining the ability to climb and descend obstacles of electrically powered wheelchairs, including scooters, intended to carry one person, with a maximum nominal speed not exceeding 15 km/h.
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
 Angela DeMarco
  FDA/OMPT/CDRH/ODE/POS/510(K)/
  301-796-4471
  angela.demarco@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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