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The Inhibitor, Model 001

by Melmedtronics, Inc.

510(k) K070648

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070648 Date29 Jun 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KLW
Device Class
Class II
Regulation
21 CFR Part 874.3400
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Inhibitor, Model 001 is a hand-held tinnitus masking device. It emits ultrasonic signals (20-60 kHz) via a piezoelectric transducer and is powered by a 3.6V lithium-ion battery.

The device is operated by the patient, with the device tip held firmly against the mastoid bone for 60-90 seconds. It is supplied as a reusable device and has received FDA 510(k) clearance under product code KLW.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is The Inhibitor Model 001 used for?

    The Inhibitor Model 001 is a hand-held tinnitus masking device designed to emit ultrasonic signals between 20-60 kHz via a piezoelectric transducer. It is intended for patient use, with the device tip held firmly against the mastoid bone for 60-90 seconds to provide tinnitus relief through sound masking.

  • Is The Inhibitor Model 001 reusable or single-use?

    The Inhibitor Model 001 is supplied as a reusable device, meaning it is designed for multiple uses over time. It is not intended for single-use disposal and can be operated repeatedly by the patient following the recommended application procedure against the mastoid bone.

  • How is The Inhibitor Model 001 powered and what are its power specifications?

    The Inhibitor Model 001 is powered by a 3.6V lithium-ion battery, which provides the necessary energy to operate the piezoelectric transducer that emits ultrasonic signals in the 20-60 kHz range. This battery is integrated into the hand-held design for portability and patient-operated use.