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510(k) Data Aggregation

    K Number
    K023000
    Device Name
    HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
    Manufacturer
    HOME CARE TECHNOLOGY CO., LTD.
    Date Cleared
    2003-10-29

    (415 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME CARE TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Specific indications: used to apply an electrical current to electrodes on patient's skin at some limited ● positions 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 supervisions for adjunctive therapy for . the treatment of medical diseases and conditions.
    Device Description
    Home Care various models of Powered Muscle Stimulator, HT-329M1, HT-329M2, HT-329M3, and HT-329M4
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    K Number
    K022998
    Device Name
    HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
    Manufacturer
    HOME CARE TECHNOLOGY CO., LTD.
    Date Cleared
    2003-05-20

    (253 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME CARE TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Specific indications: used to apply an electrical current to electrodes on patient's 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 supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
    Device Description
    Home Care various models of Powered Muscle Stimulator, HT-311, HT-311N, HT-312
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME CARE TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K022917
    Device Name
    HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
    Manufacturer
    HOME CARE TECHNOLOGY CO., LTD.
    Date Cleared
    2003-03-04

    (182 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME CARE TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
    Device Description
    Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series
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