Search Results
Found 1 results
510(k) Data Aggregation
K Number
K070648Device Name
THE INHIBITOR, MODEL 001
Manufacturer
Date Cleared
2007-06-29
(113 days)
Product Code
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
MELMEDTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to be used for the temporary relief of tinnitus. The unit emits an ultrasonic signal that masks or inhibits the sound of timitus in many afflicted individuals. The tip of the device is placed firmly against the bone behind the ear and held in place until the device goes off (60-90 seconds).
This is a medical device and should only be used with the advice of a physician, audiologist or licensed hearing aid dispenser. Only adults 18 years of age and older should be dispensed an instrument.
Device Description
The Inhibitor" is a hand-held device that emits a ultrasonic signal in the range of 20 – 60 kHz (depending on the resonant frequency of the Piezo element used). It is powered by a 3.6 V Lithium ion rechargeable battery. The transducer is a piezoelectric element. The acoustic output is <100 mW/cm2.
Ask a Question
Ask a specific question about this device
Page 1 of 1