Data / Medical devices / United States / Noctrix Health, Inc.
Noctrix Health, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 1 510(k) clearance
Noctrix Health, Inc. is registered with the FDA (registration 3025729280) in Pleasanton, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3025729280
- Address
- 6700 Koll Center Pkwy Ste 310, Pleasanton, CA, United States, 94566
- Owner or operator
- Noctrix Health, Inc. (10087959)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 5, 2023
- Registered through
- 2026
- Brand names listed
- NTX100 Tonic Motor Activation (NTX100 TOMAC) System, NTX150 Tonic Motor Activation (NTX150 TOMAC) System, Nidra Tonic Motor Activation (TOMAC) System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve, For Restless Legs Syndrome | QWD | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 17, 2023 | DEN220059 | NTX100 Tonic Motor Activation (NTX100 ToMAc) System | QWD | Unknown | Noctrix Health, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 17, 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.