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510(k) Data Aggregation
K Number
K142471Device Name
Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
Manufacturer
Pressure Point Inc.
Date Cleared
2014-12-01
(89 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Pressure Point Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pressure Right® is a drug-free, Single-Use, Pressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.
Device Description
The Pressure Right device is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.
The Pressure Right device has a three-quarter wrist size design (5.50″ long X 1.0″ wide) with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.
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