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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 a medical device manufactured by Jiangsu Betterlife Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-17 under approval 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. It is manufactured by Jiangsu Betterlife Medical Co., Ltd.. The 510(k) number is K163094.

When was TinniLogic Mobile Tinnitus Management Device approved by the FDA?

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

What company makes TinniLogic Mobile Tinnitus Management Device?

TinniLogic Mobile Tinnitus Management Device is manufactured by Jiangsu Betterlife Medical Co., Ltd..

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

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

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Related Devices (Code: KLW)

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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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