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510(k) Data Aggregation

    K Number
    K211823
    Device Name
    Bonine Acupressure Bands
    Manufacturer
    WellSpring Pharmaceutical Corporation
    Date Cleared
    2021-09-01

    (79 days)

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

    WellSpring Pharmaceutical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bonine Acupressure Bands 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
    Bonine Acupressure Bands are acupressure devices made of comfortable fabric band straps with Velcro closures and a dome on the buckle. Bonine Acupressure Band's acupressure dome provides gentle pressure on the Nei-Kuan or P6 pressure point in the wrist. The amount of pressure applied is fully adjustable and allows the user to increase or decrease as needed. Bonine Acupressure Bands are provided for over-the-counter use to be worn directly as desired on the consumer's wrists.
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