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510(k) Data Aggregation

    K Number
    K091045
    Device Name
    SMART TENS, MODEL: D-BC05T
    Manufacturer
    BODY CLOCK HEALTH CARE LTD
    Date Cleared
    2009-12-18

    (249 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODY CLOCK HEALTH CARE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    Not Found
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    K Number
    K041359
    Device Name
    BODY CLOCK STIMPLUS AND STIMPLUS PRO
    Manufacturer
    BODY CLOCK HEALTH CARE LTD
    Date Cleared
    2004-08-20

    (91 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODY CLOCK HEALTH CARE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Body Clock Stimplus Pro and Body Clock Stimplus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the symptomatic relief and management of post-surgical and post-traumatic acute pain.
    Device Description
    The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.
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    K Number
    K022849
    Device Name
    BODY CLOCK TENS N' TONE
    Manufacturer
    BODY CLOCK HEALTH CARE LTD
    Date Cleared
    2003-05-20

    (266 days)

    Product Code
    GZJ, IPF
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODY CLOCK HEALTH CARE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a TENS unit, the Body Clock Duo is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. As a Powered Muscle Stimulator unit the Body Clock Duo is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following: - Relaxation of muscle spasms; ● - Prevention or retardation of disuse atrophy; ● - Increasing local blood circulation; ● - Muscle re-education; ● - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and . - Maintaining or increasing range of motion. ●
    Device Description
    The Body Clock Duo has two facilities, enabling it to function as both a TENS unit and as a Powered Muscle Stimulator. As a TENS unit, the Body Clock Duo transmits electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain. As a Powered Muscle Stimulator, the Body Clock Duo can be used to relax muscle spasms, prevent or retard disuse atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.
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    K Number
    K021846
    Device Name
    804SIII; 804W; LIBRA TENS; 410; S-TENS II
    Manufacturer
    BODY CLOCK HEALTH CARE LTD
    Date Cleared
    2002-11-22

    (170 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODY CLOCK HEALTH CARE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 804SIII, 804W, Libra TENS, 410 and S-TENSII are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain.
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    K Number
    K022731
    Device Name
    V TENS PLUS
    Manufacturer
    BODY CLOCK HEALTH CARE LTD
    Date Cleared
    2002-11-14

    (90 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODY CLOCK HEALTH CARE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V TENS Plus is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.
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    K Number
    K022493
    Device Name
    EMS 400
    Manufacturer
    BODY CLOCK HEALTH CARE LTD
    Date Cleared
    2002-10-11

    (74 days)

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

    BODY CLOCK HEALTH CARE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Body Clock EMS 400 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following: - Relaxation of muscle spasms; - Prevention or retardation of disuse atrophy; - Increasing local blood circulation; - Muscle re-education; - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and - Maintaining or increasing range of motion.
    Device Description
    The EMS 400 a dual channel EMS (Powered Muscle Stimulator) unit. It is identical to the Altoona EMS 400 (K913272). It has two intensity (amplitude) dials for each channel, placed on the front of the unit. Directly below the left-hand-side intensity dial is a pulse rate dial, which sets the pulse rate for both channels. Below the right-hand dial is a timer dial, which controls the time of each cycle when cycle or reciprocal mode is used. If the dial is set to 0, the unit provides a constant mode.
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    K Number
    K022076
    Device Name
    FIRST CHOICE & FIRST CHOICE PLUS
    Manufacturer
    BODY CLOCK HEALTH CARE LTD
    Date Cleared
    2002-09-24

    (90 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODY CLOCK HEALTH CARE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The First Choice and First Choice Plus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain.
    Ask a Question

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