The following data is part of a premarket notification filed by Nalu Medical, Inc. with the FDA for Nalu Neurostimulation System.
| Device ID | K203547 |
| 510k Number | K203547 |
| Device Name: | Nalu Neurostimulation System |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | Nalu Medical, Inc. 2320 Faraday Ave. Suite 100 Carlsbad, CA 92008 |
| Contact | Pauline Lieu |
| Correspondent | Pauline Lieu Nalu Medical, Inc. 2320 Faraday Ave. Suite 100 Carlsbad, CA 92008 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-04 |
| Decision Date | 2021-03-25 |