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510(k) Data Aggregation

    K Number
    K041877
    Device Name
    ACU-STRAP MOTION SICKNESS BAND
    Manufacturer
    HEALTH ENT., INC.
    Date Cleared
    2004-10-08

    (88 days)

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

    HEALTH ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acu-Strap™ Travel and Motion Sickness Band is intended for the relief of nausea. Nausea may be experienced due to Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia or Chemotherapy.
    Device Description
    The Acu-Strap™ Travel and Motion Sickness Band product comprises a pair of wristbands, each with a round button added to the interior face of the band. Because the Acu-Strap™ Travel and Motion Sickness Band is stretchable, it will be sold in only one size. The Acu-Strap™ Travel and Motion Sickness Band operates by placing a constant pressure on an acupressure point (the P6 or "Nei-Kuan" point) near the wrist.
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