ISO 7176-2 Third edition 2017-10

Wheelchairs - Part 2:Determination Of Dynamic Stability Of Electrically Powered Wheelchairs

7176-2 Third edition 2017-10

Standard Organization: ISO

ISO 7176-2 Third edition 2017-10
Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs

Recognition NumberPhysical Medicine
Recognition Date2018-09-17
Recognition List050
Recognition Number16-202
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Physical Medicine
FDA Tech  Angela DeMarco   FDA/OMPT/CDRH/ODE/POS/510(K)/   301-796-4471   angela.demarco@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies

Scope:

This document specifies test methods for determining the dynamic stability of electrically powered wheelchairs.This document is applicable to electrically powered wheelchairs, including scooters, with a maximum nominal speed not exceeding 15 km/h, intended to carry one person. This document is not applicable to manual wheelchairs with add-on power kits used for, or to assist, propulsion.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI

FDA Guidance:

Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995.


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