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510(k) Data Aggregation

    K Number
    K023001
    Device Name
    HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
    Manufacturer
    HOME CARE TECHNOLOGY CO., LTD.
    Date Cleared
    2003-04-08

    (211 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Specific Indications: Used to apply an electrical current to electrodes on patients skin to function as:

    • . Relaxation of muscle spasms.
    • Prevention or retardation of disuse atrophy. .
    • Muscle re-education. ●
    • Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis.
    • Maintaining or increasing range of motion. .

    Clinical settings: The device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

    Device Description

    Not Found

    AI/ML Overview

    The provided document describes an FDA 510(k) clearance for the Homecare HT-326L device, a powered muscle stimulator. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is primarily an approval letter confirming substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information.

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