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

16-164

Standard

ISO 7176-10 Second edition 2008-11-01
Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs

Scope/Abstract

ISO 7176-10:2008 specifies test methods for determining the ability to climb and descend obstacles of electrically powered wheelchairs, including scooters, intended to carry one person, with a maximum nominal speed not exceeding 15 km/h.

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

Angela DeMarco

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

301-796-4471

Angela.Demarco@fda.hhs.gov

Kathryn Delaurentis

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

240-402-4911

kathryn.delaurentis@fda.hhs.gov

Amir Razjouyan

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

301-796-2701