Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TinniLogic Mobile Tinnitus Management Device

K-Number: K163094 · 2017-05-17

ApplicantJiangsu Betterlife Medical Co., Ltd.
Decision Date2017-05-17
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TinniLogic Mobile Tinnitus Management Device is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Betterlife Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-17 under 510(k) number K163094. 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 TinniLogic Mobile Tinnitus Management Device?

TinniLogic Mobile Tinnitus Management Device is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Jiangsu Betterlife Medical Co., Ltd.. The 510(k) number is K163094.

When did TinniLogic Mobile Tinnitus Management Device receive FDA 510(k) clearance?

TinniLogic Mobile Tinnitus Management Device received FDA 510(k) clearance on 2017-05-17, under 510(k) number K163094.

Who is the listed applicant for TinniLogic Mobile Tinnitus Management Device?

The FDA 510(k) record lists Jiangsu Betterlife Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TinniLogic Mobile Tinnitus Management Device?

The FDA product code for TinniLogic Mobile Tinnitus Management Device is KLW.

Related Devices (Code: KLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK233435Peace N Quiet (0.7.0)Pnq HealthK223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity ABK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

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.

↑