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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 16-234
Standard
ISO  7176-14 Third Edition 2022
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
Scope/Abstract
This document specifies requirements and associated test methods for the power, and control systems of electrically powered wheelchairs and scooters. It sets safety and performance requirements that apply during normal use and some conditions of abuse and failure. It also specifies methods of measurement of the forces necessary to operate controls and sets limits on the forces needed for some operations.
This document is applicable to electrically powered wheelchairs and scooters with a maximum speed no greater than 15 km/h intended to provide indoor and/or outdoor mobility for one disabled person whose mass lies in the range specified in ISO 7176-11.
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FDA recognition of ISO 7176-14 Second edition 2008-02-15 [Rec# 16-165] will be superseded by recognition of ISO 7176-14 Third Edition 2022 [Rec# 16-234]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-165] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 16-165] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Amir Razjouyan
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB
  301-796-2701
  Amir.Razjouyan@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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