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

16-27

Standard

ISO 7176-15 First edition 1996-11-15
Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling

Scope/Abstract

This standard specifies the information, documentation and labelling to be provided with a wheelchair at the supply by 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
§890.3850	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
§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

Kathryn Delaurentis

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

240-402-4911

kathryn.delaurentis@fda.hhs.gov

Angela DeMarco

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

301-796-4471

Angela.Demarco@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization