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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 16-159
Standard
ISO 7176-2 Second edition 2001-06-15
Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
Extent of Recognition
Complete standard
Transition Period
FDA recognition of ISO 7176-2 Second edition 2001-06-15 [Rec# 16-159] will be superseded by recognition of ISO 7176-2 Third edition 2017-10 [Rec# 16-202]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-159] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 16-159] 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
§890.3900 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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