Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

051

Date of Entry 01/14/2019

FR Recognition Number

16-204

Standard

ISO 7176-6 Third edition 2018-06
Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs

Scope/Abstract

This document specifies test methods for determining the maximum speed of electrically powered wheelchairs, including scooters, intended to carry one person with a maximum nominal speed not exceeding 15 km/h (4,167 m/s) on a level surface.

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.

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/OHTV/DHTVB/

240-402-4911

kathryn.delaurentis@fda.hhs.gov

Amir Razjouyan

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

301-796-2701