# K163094: TinniLogic Mobile Tinnitus Management Device

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Betterlife Medical Co., Ltd.
- Decided: May 17, 2017 after 194 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K974501 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140845: Levo Tinnitus Masking Software Device, Otoharmonics Corp (2014) Summary page 5.
- K111293: Soundcure Serenade Tinnitus Treatment System, Soundcure, Inc. (2011) Summary page 5.

## Indications for use
The TinniLogic Mobile Tinnitus Management Device is indicated for use in the temporary relief of tinnitus symptoms. The device is a player to play customized sounds and display professional counseling or education to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

Source page: https://510kreport.com/device/K163094
Methodology: https://510kreport.com/methodology