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510(k) Data Aggregation

    K Number
    K091236
    Device Name
    MANTRA COMBO, MODEL MECS 320
    Date Cleared
    2009-07-30

    (94 days)

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

    MANTRA INTL. (HK) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    a. TENS: The device is intended 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 pair. b. NMS: The device in recommended for use for the following conditions: 1. Relaxation of muscle spasms 2. Prevention of retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6. Maintaining and increasing range of motion.
    Device Description
    The "Mantra Combo" combined TENS and NMS dual channel device is housed in small lightweight cabinet and is battery powered. The same circuitry is used to for both TENS and NMS.
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    K Number
    K041902
    Device Name
    MANTRA ELECTRODE
    Date Cleared
    2004-09-22

    (70 days)

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

    MANTRA INTL. (HK) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mantra Electrode is intended to be used with Transcutaneous Nerve Stimulator and Electronic Muscle Stimulator Units.
    Device Description
    The Mantra Electrode is a multi-layer structure containing conducting material and one of several types of connectors. The electrode is a multi-layer structure consisting of a layer of hydrogel, conducting film and a non-woven backing material. Various connectors can be used with the electrodes: (1) snap type lead wires for button connector type electrodes, (2) button type clectrodes, and (3) tab type electrodes.
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    K Number
    K041520
    Device Name
    MANTRA TENS MODEL NT3
    Date Cleared
    2004-09-03

    (88 days)

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

    MANTRA INTL. (HK) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for the symptomatic relief of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
    Device Description
    The Mantra TENS Model NT3 is a Dual Channel Transcutaneous Nerve Stimulator (TENS).
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