Data / Medical devices / Taiwan / Somnics, Inc.
Somnics, Inc.: FDA-registered device maker in Zhubei City Hsinchu(County), Taiwan, 2 510(k) clearances
Somnics, Inc. is registered with the FDA (registration 3014674517) in Zhubei City Hsinchu(County), Taiwan. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014674517
- Address
- 5F, No. 22, Sec. 2, Shengyi Rd., Hsinchu Science Park, Zhubei City Hsinchu(County), Taiwan, 30261
- Owner or operator
- Somnics, Inc. (10058120)
- Roles
- Manufacturer
- First device listed
- May 26, 2020
- Registered through
- 2026
- Brand names listed
- The iNAP One Sleep Therapy System, ZEEPAP, ZeeBud, iNAP One Sleep Therapy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Nasal | LWF | 1 | Manufacturer | accessdata.fda.gov |
| Intraoral Pressure Gradient Device | OZR | 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 |
|---|---|---|---|---|---|---|
| June 16, 2023 | K220907 | The iNAP One Sleep Therapy System | OZR | Substantially Equivalent | Somnics, Inc. | accessdata.fda.gov |
| May 26, 2020 | K193460 | The iNAP One Sleep Therapy System | OZR | Substantially Equivalent | Somnice, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 16, 2023. 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.