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510(k) Data Aggregation

    K Number
    K230782
    Device Name
    TENS device-HeadaTerm 2 (Model: YF-HT2)
    Manufacturer
    WAT Medical Technology Inc.
    Date Cleared
    2024-02-26

    (341 days)

    Product Code
    PCC
    Regulation Number
    882.5891
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAT Medical Technology Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
    Device Description
    TENS device-HeadaTerm 2 offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS device- HeadaTerm 2 enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort. The device could adhere to patient's forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, the product provides the user with 9 gear options, and the user can control the stimulating intensity by selecting one of gear.
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    K Number
    K220503
    Device Name
    TENS device-EmeTerm 2, Model: YF-ZTY-E2
    Manufacturer
    WAT Medical Technology Inc.
    Date Cleared
    2022-04-23

    (60 days)

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

    WAT Medical Technology Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS device-EmeTerm 2 is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
    Device Description
    TENS device-EmeTerm 2 is a single-patient use wearable device, rechargeable, non-invasive device that is worn on the wrist like a watch. It is a non-invasive device that is indicated for the over-the-counter use in the relief of mild to moderate nausea and vomiting, motion sickness, mild to moderate nausea and vomiting associated with pregnancy. TENS device-EmeTerm 2 includes a Rubber wristband with two electrodes must be placed at the center of the inner wrist, about 2 to 3cm from the wrist crease. The electrodes in the wristband provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.
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