Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

031

Date of Entry 08/06/2013 

FR Recognition Number

16-192

Standard

ISO  7176-3 Third edition 2012-12-15
Wheelchairs - Part 3: Determination of effectiveness of brakes

Scope/Abstract

ISO 7176-3:2012 specifies test methods for the measurement of the effectiveness of brakes of manual wheelchairs and electrically powered wheelchairs, including scooters, intended to carry one person, with a maximum speed not exceeding 15 km/h. It also specifies disclosure requirements for the manufacturer.

Extent of Recognition

Complete standard

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

 Angela DeMarco

  FDA/OC/CDRH/OPEQ/ORP/DRPI/

  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

*These are provided as examples and others may be applicable.