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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 16-202
Standard
ISO 7176-2 Third edition 2017-10
Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
Scope/Abstract
This document specifies test methods for determining the dynamic stability of electrically powered wheelchairs.This document is applicable to electrically powered wheelchairs, including scooters, with a maximum nominal speed not exceeding 15 km/h, intended to carry one person. This document is not applicable to manual wheelchairs with add-on power kits used for, or to assist, propulsion.
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FDA recognition of ISO 7176-2 Second edition 2001-06-15 [Rec# 16-159] will be superseded by recognition of ISO 7176-2 Third edition 2017-10 [Rec# 16-202].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
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995.
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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