K Number
K251285Device Name
Electric Wheelchair (HG-630)
Manufacturer
Date Cleared
2025-07-02
(68 days)
Product Code
Regulation Number
890.3860AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
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