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FDA 510(k)

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System

K-Number: K151558 · 2016-01-20

ApplicantNeurotherapies Reset GmbH
Decision Date2016-01-20
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System is a medical device manufactured by Neurotherapies Reset GmbH. It received FDA 510(k) clearance on 2016-01-20 under approval number K151558. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System?

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System is a medical device that received FDA 510(k) clearance on 2016-01-20. It is manufactured by Neurotherapies Reset GmbH. The 510(k) number is K151558.

When was Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System approved by the FDA?

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System received FDA 510(k) clearance on 2016-01-20, under approval number K151558.

What company makes Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System?

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System is manufactured by Neurotherapies Reset GmbH.

What is the FDA product code for Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System?

The FDA product code for Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System is KLW.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Related Devices (Code: KLW)

K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc. K161331HyperSound Tinnitus ModuleTurtle Beach Corporation K171243audifon Tinnitus-ModuleAudiofon USA, Inc. K163094TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd. K180495Tinnitus Sound Generator ModuleGN Hearing A/S K181586Tinnitus Sound Generator ModuleGN Hearing A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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