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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 16-194
ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
Scope/Abstract
ISO 7176-25:2013 specifies requirements and test methods for batteries and battery chargers intended for use with electrically powered wheelchairs. It is applicable to lead acid batteries and chargers intended for use with them. Requirements for chargers are applicable to those with a rated input voltage not greater than 250 V a.c. and a nominal output voltage not greater than 36 V.
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
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3860 Wheelchair, Powered Class 2 ITI
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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