Data / Medical devices / United States / Boyd Research
Boyd Research: FDA-registered device maker in St Pete Beach, FL, United States, 3 510(k) clearances
Boyd Research is registered with the FDA (registration 3010767848) in St Pete Beach, FL, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 17, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010767848
- Address
- 5820 Bali Way S, St Pete Beach, FL, United States, 33706
- Owner or operator
- Boyd Research, Inc. (10042732)
- Roles
- Manufacturer
- First device listed
- December 21, 2012
- Registered through
- 2026
- Brand names listed
- NTI, NTI Duo, NTI MigraineGuard, NTI-tss, SnoreHook, TRIGENA, Trigena
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Migraine/Tension Headache | OCO | U | Manufacturer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | 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 |
|---|---|---|---|---|---|---|
| September 17, 2021 | K211158 | NTI ClenchGuard | OBR | Substantially Equivalent | Boyd Research, Inc. | accessdata.fda.gov |
| May 3, 2005 | K041184 | NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION | LRK | Substantially Equivalent | Nti-Tss, Inc. | accessdata.fda.gov |
| June 20, 2001 | K010876 | NTI TENSION SUPPRESSION SYSTEM | OCO | Substantially Equivalent | Nti-Tss, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Migraine/Tension Headache
- All makers of Mouthguard, Over-The-Counter
- All makers of Mouthguard, Prescription
- All makers of Device, Anti-Snoring
Updated September 17, 2021. 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.