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510(k) Data Aggregation

    K Number
    K193374
    Device Name
    TumEase Acupressure Bracelets
    Manufacturer
    MumEase
    Date Cleared
    2020-03-04

    (90 days)

    Product Code
    MVV
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MumEase

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The acupressure bracelets are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
    Device Description
    The TumEase Acupressure bracelet is a wrist bracelet that has a small round bump on the inside face of the bracelet. This small bump is manually aligned with the P6 (Neiguan or Pericardium) acupressure point. The bracelet is affixed using a Velcro strap and the desire amount of pressure is applied. One key design feature is the ability to adjust the pressure level using the "tightness" of the Velcro strap. More pressure generally increases the desired anti-nausea affect. The functionality of the Veloro strap allows each patient the ability to find the right amount of pressure for themselves based on their condition and needs. In addition, the TumEase bracelets are designed to be cosmetically attractive. It is supplied to the counter (non-sterile). The acupressure bracelets are intended to be worn over a thin fabric. It can be used as frequently as needed by the patient.
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