The following data is part of a premarket notification filed by Jiangsu Betterlife Medical Co., Ltd. with the FDA for Tinnilogic Mobile Tinnitus Management Device.
| Device ID | K163094 |
| 510k Number | K163094 |
| Device Name: | TinniLogic Mobile Tinnitus Management Device |
| Classification | Masker, Tinnitus |
| Applicant | JIANGSU BETTERLIFE MEDICAL CO., LTD. NO.11 SI HAI ROAD, CHANGSHU ECONOMIC AND TECHNICAL DEVELOPMENT PARK Changshu, CN 215513 |
| Contact | Hongwei Xu |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-04 |
| Decision Date | 2017-05-17 |
| Summary: | summary |