Data / Medical devices / United States / Neuralace Medical
Neuralace Medical: FDA-registered device maker in San Marcos, CA, United States, 2 510(k) clearances
Neuralace Medical is registered with the FDA (registration 3015617003) in San Marcos, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 10, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015617003
- Address
- 1621 S Rancho Santa Fe Rd Ste F, San Marcos, CA, United States, 92078
- Owner or operator
- Neuralace Medical (10082128)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 17, 2021
- Registered through
- 2027
- Brand names listed
- Axon Therapy
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electromagnetic Stimulator, Pain Relief | QPL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 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 |
|---|---|---|---|---|---|---|
| January 10, 2024 | K233364 | Axon Therapy | QPL | Substantially Equivalent | Neuralace Medical, Inc. | accessdata.fda.gov |
| June 11, 2021 | K210021 | Axon Therapy | QPL | Substantially Equivalent | Neuralace Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 10, 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.