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510(k) Data Aggregation
K Number
K070766Device Name
PSI BANDS
Manufacturer
PSI HEALTH SOLUTIONS, INC.
Date Cleared
2007-07-26
(128 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PSI HEALTH SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Psi Bands are 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
- chemotherapy.
Psi Bands are intended for over-the-counter use.
Device Description
Psi Bands, acupressure (pressure stimulation) wrist bands, consist of a plastic orb that applies pressure to the Nei-kuan (P6) acupressure point, the area that provides nausea relief. Psi Bands may be worn on both wrists at the same time and may be adjusted at two areas: 1) around the wrist like a watch, and 2) at the acupressure point by turning a plastic dial clock-wise. The plastic dial allows the user to apply different degrees of pressure at the acupressure point for maximum comfort and effectiveness. Select from one of three settings (mild nausea = low pressure; moderate nausea = medium pressure; troublesome nausea = high pressure). By turning the dial past the highest setting, the dial will automatically return to its neutral, or lowest, setting so that it cannot be overtightened.
Psi Bands are made from synthetic rubber, specifically medical grade Santoprene™ thermoplastic rubber and food grade ABS plastic which does not directly contact the patient after adjustment.
Components of the system include:
Strap and collar made of medical grade Santoprene™ thermoplastic rubber
Button is composed of three parts; the dial, the nut and the ring all made of food grade ABS plastic and which reside inside the button itself which is part of the Santoprene™strap
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