Data / Medical devices / China / Jiangsu Betterlife Medical Co., Ltd.
Jiangsu Betterlife Medical Co., Ltd.: FDA-registered device maker in Jiangsu, China, 1 510(k) clearance
Jiangsu Betterlife Medical Co., Ltd. is registered with the FDA (registration 3010197022) in Jiangsu, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 17, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010197022
- Address
- 11 Sihai Rd. Changshu Economic Development Zone, Jiangsu, China, 215513
- Owner or operator
- Jiangsu BetterLife Medical Co., Ltd. (10042660)
- Roles
- Manufacturer
- First device listed
- December 17, 2012
- Registered through
- 2026
- Brand names listed
- Charming, Elegant, Harmony, TinniLogic Mobile Tinnitus Management Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Face Plate Hearing Aid | LRB | 1 | Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Manufacturer | accessdata.fda.gov |
| Masker, Tinnitus | KLW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 17, 2017 | K163094 | TinniLogic Mobile Tinnitus Management Device | KLW | Substantially Equivalent | Jiangsu Betterlife Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- All makers of Hearing Aid, Air-Conduction, Prescription
- All makers of Masker, Tinnitus
- All makers of Face Plate Hearing Aid
Updated May 17, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.