The following data is part of a premarket notification filed by Nalu Medical, Inc with the FDA for Nalu Neurostimulation Scs System.
| Device ID | K201618 |
| 510k Number | K201618 |
| Device Name: | Nalu Neurostimulation SCS System |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | Nalu Medical, Inc 2320 Faraday Ave. Suite 100 Carlsbad, CA 92008 |
| Contact | Michele Chin-purcell |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2020-07-15 |