Data / Medical devices / United States / Slow Wave, Inc.
Slow Wave, Inc.: FDA-registered device maker in Lakeway, TX, United States, 2 510(k) clearances
Slow Wave, Inc. is registered with the FDA (registration 3017520337) in Lakeway, TX, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017520337
- Address
- 1150 Lakeway Dr Ste 213, Lakeway, TX, United States, 78734
- Owner or operator
- Slow Wave, Inc. (10078388)
- Roles
- Manufacturer
- First device listed
- October 20, 2020
- Registered through
- 2026
- Brand names listed
- BROSA, DS8, Slow Wave DS8
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Migraine/Tension Headache | OCO | U | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | 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 4, 2024 | K240463 | Slow Wave DS8 (SWDS802) | MQC | Substantially Equivalent | Slow Wave, Inc. | accessdata.fda.gov |
| October 2, 2020 | K191320 | Slow Wave DS8 | LQZ | Substantially Equivalent | Slow Wave, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Migraine/Tension Headache
- All makers of Mouthguard, Prescription
- All makers of Device, Anti-Snoring
- All makers of Device, Jaw Repositioning
Updated June 4, 2024. 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.