Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K172450
    Device Name
    TENS device-HeadaTerm, eEspress
    Manufacturer
    WAT Medical Technology (Ningbo) Co., Ltd
    Date Cleared
    2018-09-13

    (395 days)

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

    WAT Medical Technology (Ningbo) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TENS device-HeadaTerm is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
    Device Description
    TENS device-HeadaTerm 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 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 patients 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, and during ramping up, patients could choose comfortable intensity level by pressing the host key to lock up the current voltage, and the patient contact material is biocompatibility safe. The conductive paste could be replaced once the paste lost its adhesiveness and patients are recommended to replace the conductive paste after 7 times of treatment uses.
    Ask a Question
    K Number
    K172478
    Device Name
    TENS device-EmeTerm, CinvStop
    Manufacturer
    WAT Medical Technology (Ningbo) Co., Ltd
    Date Cleared
    2018-04-19

    (246 days)

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

    WAT Medical Technology (Ningbo) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EmeTerm CinvStop is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
    Device Description
    TENS device-EmeTerm generates the electric pulses with highly specific waveforms, frequency and amplitude to stimulate the median nerve. The accurate pulse signals provide relief through electrical stimulation of the nerves in the patient's wrist.
    Ask a Question

    Page 1 of 1