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510(k) Data Aggregation
K Number
K110563Device Name
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP
Manufacturer
THERAPEUTICS 101, INC (DBA PRESSURE POINT, INC.)
Date Cleared
2011-04-08
(39 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
THERAPEUTICS 101, INC (DBA PRESSURE POINT, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is indicated for the relief of emetic (nausea and vomiting) symptoms associated with Post-Operative Anesthesia.
Device Description
The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip 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″ 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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