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510(k) Data Aggregation

    K Number
    K051397
    Device Name
    BIOBANDS
    Manufacturer
    BIOBANDS DISTRIBUTORS, INC.
    Date Cleared
    2005-09-16

    (112 days)

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

    BIOBANDS DISTRIBUTORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioBands is indicated for the relief of nausea. Nausea may be experienced due to a variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.
    Device Description
    BioBands is an adjustable wristband that fits on either wrist. The device is composed from nylon and polyester fabric, and features a Velcro closure for easy adjustment. The BioBands wristband has a wooden bead or button sewn into the band's underside. When BioBands is worn by users, the wooden bead applies pressure to the P6 or "nei-kuan" acupuncture point. The gentle pressure applied by the bead to the P6 interrupts the signals that trigger nausea.
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