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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 049 Date of Entry 06/07/2018 
FR Recognition Number 16-201
Standard
ISO  7176-19 Second Edition 2008-07-15
Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)]
Scope/Abstract
This part of ISO 7176 applies to all manual and powered wheelchairs, including scooters, which, in addition to their primary function as wheeled mobility devices, are also likely to be used as forward-facing seats in motor vehicles by children and adults with a body mass equal to or greater than 22 kg. This part of ISO 7176 specifies wheelchair design requirements, performance requirements and associated test methods, and requirements for wheelchair labelling, presale literature, user instructions and user warnings. It applies to complete wheelchairs, including a base frame and seating system, as well as to wheelchairs equipped with add-on adaptive components designed to facilitate compliance with one or more of the requirements.
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FDA recognition of ISO 7176-19 Second Edition 2008-07-15 [Rec# 16-201] will be superseded by recognition of ISO 7176-19 Third Edition 2022 [Rec# 16-236]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-201] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 16-201] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
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.

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
 Kathryn Delaurentis
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  240-402-4911
  kathryn.delaurentis@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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