ISO 7176-4 Third edition 2008-10-01

Standard Organization:

ISO 7176-4 Third edition 2008-10-01
Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range

Recognition Date2014-01-30
Recognition List034
Recognition Number16-162
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Physical Medicine
FDA Tech  John Marszalek   FDA/OMPT/CDRH/OC/DICO/FEB/   301-796-7067   john.marszalek@fda.hhs.gov

Rationale:

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Scope:

ISO 7176-4:2008 specifies methods for determining theoretical distance range of electrically powered wheelchairs, including scooters, using measurements of energy consumed while driving and the nominal energy capacity of the wheelchair's battery set. It is applicable to electrically powered wheelchairs with a maximum nominal speed no greater than 15 km/h, intended to provide indoor and/or outdoor mobility for one disabled person whose mass is within the range represented by ISO 7176-11. ISO 7176-4:2008 also includes requirements for test reports and information disclosure.

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:

There is no relevant guidance developed at this time.


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