Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

034

Date of Entry 01/30/2014

FR Recognition Number

16-167

Standard

ISO 7176-9 Third edition 2009-11-15
Wheelchairs - Part 9: Climatic tests for electric wheelchairs

Scope/Abstract

ISO 7176-9:2009 specifies requirements and test methods to determine the effects of rain, dust, condensation and the effects of changes of temperature on the basic functioning of electrically powered wheelchairs, including scooters, intended to carry one person, with a maximum speed not exceeding 15 km/h.

ISO 7176-9:2009 does not include requirements for resistance to corrosion.

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 Contacts

Amir Razjouyan

FDA/OC/CDRH/OPEQ/OHTV/DHTVB

301-796-2701

Amir.Razjouyan@fda.hhs.gov

Angela DeMarco

FDA/OC/CDRH/OPEQ/ORP/DRPI/

301-796-4471

Angela.Demarco@fda.hhs.gov

Kathryn Delaurentis

FDA/OC/CDRH/OPEQ/OHTV/DHTVB/

240-402-4911