NALU MEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015425075 | 3015425075 | NALU MEDICAL | 1 | N | 2026-01-01 | 2320 Faraday Ave. Suite 100 Carlsbad CA US 92008 |
| 3015425075 | 3015425075 | NALU MEDICAL | 1 | N | 2020-04-25 | 2320 Faraday Ave. Suite 100 Carlsbad CA US 92008 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 348645 | 1843249514 | K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | GZB | 2024-08-23 |
| 228581 | 1780933186 | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits | GZF | 2019-03-29 |
| 228581 | 1198193506 | K183047 | Nalu Neurostimulation System | GZB | 2019-03-22 |