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510(k) Data Aggregation

    K Number
    K192733
    Device Name
    RelieforMe TENS/EMS Device Model UPK-GE01
    Manufacturer
    Umeheal Ltd.
    Date Cleared
    2019-12-23

    (87 days)

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

    Umeheal Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: 1. It is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (legs), upper extremities (arms) due to strain from exercise or normal household and work activities. 2. It is also intended for symptomatic relief and management of chronic, intractable pain associated with arthritis. EMS: 3. To stimulate healthy muscles to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the intended areas on the body. 4. To be used for relaxation of muscle spasm, increase of blood flow circulation, prevention or retardation of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    RelieforMe TENS/EMS Device model UPK-GE01 is designed to focus on pain relief, muscle strengthening and recovery features with TENS/EMS treatment techniques driven and controlled by intelligent programs/software. RelieforMe TENS/EMS Device, a TENS/EMS combination device, is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (leg), upper extremities (arm) due to strain from exercise or normal household and work activities. The device is for 18 and older. The device provides pain relief based on the intelligent use of the key pain-killer mechanisms of TENS (Transcutaneous Electrical Nerve Stimulation).
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