The following data is part of a premarket notification filed by Neuralace Medical, Inc. with the FDA for Axon Therapy.
| Device ID | K210021 |
| 510k Number | K210021 |
| Device Name: | Axon Therapy |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | NeuraLace Medical, Inc. 3770 Tansy St #101 San Diego, CA 92121 |
| Contact | Joe Milkovits |
| Correspondent | Allison C. Komiyama AcKnowledge Regulatory Strategies LLC 2251 San Diego Ave, Suite B-257 San Diego, CA 92121 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08592566001055 | K210021 | 000 |
| 08592566478314 | K210021 | 000 |
| 08592566476556 | K210021 | 000 |
| 08592566471506 | K210021 | 000 |
| 08592566410567 | K210021 | 000 |