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510(k) Data Aggregation
K Number
K110821Device Name
BARF BAND
Manufacturer
DOODLEBUG PRODUCTS, LLC
Date Cleared
2012-02-27
(340 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DOODLEBUG PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barf Band is indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example: pregnancy (morning sickness), motion sickness, anesthesia and chemotherapy.
Device Description
The Barf Band is a wristband with adjustable properties that operates by putting pressure on Nei Kuan acupressure point (also known as the P6 point) on each wrist by means of a plastic dome/stud. Barf Bands are made from PVC free polyurethane, ABS plastic covered with Santoprene and 100% cotton. The band itself is composed of polyurethane. The ABS plastic covered with Santoprene is used to construct the plastic dome/stud that applies the pressure to the P6 point. The cotton is used inside the band to make the band comfortable to the end user.
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