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510(k) Data Aggregation
K Number
K211823Device Name
Bonine Acupressure Bands
Manufacturer
WellSpring Pharmaceutical Corporation
Date Cleared
2021-09-01
(79 days)
Product Code
MVV
Regulation Number
N/AWhy 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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