Trade Name: The InhibitorTM Common Name: Tinnitus Masking ...
JUN 2 9 Zoo,
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510 (k) Summary
Applicant's/Submitter's Name/Address:
Melmedtronics, Inc. 1550 Norwood Dr., Suite 100 Hurst, TX 76054
Contact Person:
David W. Holmes, Ph.D.
Telephone/Fax:
817-268-1564 voice 817-285-6182 fax email:
Date of Summary:
Device Name:
Trade Name:
Common Name: Classification Name:
March 5, 2007
The InhibitorTM Tinnitus Masking Device Ultra Sonic Tinnitus Masker
Registration Number: Regulatory Class: Regulation Number: Product Code: Performance Standards:
Device)
Starkey Labs)
None Assigned Class 11
21 CFR 874.3400
77KLW
Substantial Equivalence to the following predicate devices: K013253 (Hearing Innovations HiSonic TDR Tinnitus Relief
K021202 (Sound Technique Systems, LLC: Ultra Quiet) K964216 (Starkey TM-3, TM-5 High Frequency Tinnitus Masker, K003559 (Siemens TCI Tinnitus Control Instrument)
Description of Device
The InhibitorTM 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 ................
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