nalumed.comNalu Neurostimulation System
Nalu Medical, Inc.
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 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00812537030258 | Nalu Medical, Inc. - EIC | 1-800-618-3402 | info@nalumed.com |
| 00812537030265 | Nalu Medical, Inc. - Electrode Interfacing Cable (EIC) (68.58 cm) is an electrical connector that mates with the proximal end of the Lead or the Lead extension external to the patient and connects with a Trial Therapy Disc (or the EIC Extension which likewise connects to the Trial Therapy Disc to provide an extension bridging the sterile field). | 1-800-618-3402 | info@nalumed.com |
| 00812537030272 | Nalu Medical, Inc. - Holds the therapy disk in place over the implantable pulse generator location. 30 clips. Standard adhesive. | 1-800-618-3402 | info@nalumed.com |
| 00812537030296 | Nalu Medical, Inc. - Holds the therapy disk in place over the implantable pulse generator location. 30 clips. Light adhesive. | 1-800-618-3402 | info@nalumed.com |
| 00812537030883 | Nalu Medical, Inc. - Holds the therapy disk in place over the implantable pulse generator location. 30 clips. Comfort adhesive. | 1-800-618-3402 | info@nalumed.com |
| 00812537036953 | Nalu Medical, Inc. - Holds the therapy disk in place over the implantable pulse generator location. 30 clips. Alternate adhesive. | 1-800-618-3402 | info@nalumed.com |
| 10812537030736 | Nalu Medical, Inc. - Limb Cuff, Large (Black) | 1-800-618-3402 | info@nalumed.com |
| 10812537035588 | Nalu Medical, Inc. - Limb Cuff (Black) | 1-800-618-3402 | info@nalumed.com |
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 |
Product Codes Associated With Registrations#
PMN#
Nalu Neurostimulation System
Nalu Medical, Inc.
Nalu Neurostimulation SCS System
Nalu Medical, Inc
IPG, Integrated, 25/40 Cm, Single, Tined, IPG, 2 Cm, Single 4, Lead (25/40 Cm, 4, Tined), Extension - 4
Nalu Medical, Inc.
Nalu Lead Blank (50cm)
Nalu Medical, Inc.
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 Miscell
Nalu Medical, Inc
Nalu Neurostimulation System
Nalu Medical, Inc
GUDID#
Nalu Medical, Inc. - Holds the therapy disk in place over the implantable pulse generator location. 30 clips. Alternate adhesive.
2026-08-07
Nalu Medical, Inc. - Holds the therapy disk in place over the implantable pulse generator location. 30 clips. Comfort adhesive.
2026-08-07
Nalu Medical, Inc. - Holds the therapy disk in place over the implantable pulse generator location. 30 clips. Light adhesive.
2026-08-07
Nalu Medical, Inc. - Holds the therapy disk in place over the implantable pulse generator location. 30 clips. Standard adhesive.
2026-08-07
Nalu Medical, Inc. - Electrode Interfacing Cable (EIC) (68.58 cm) is an electrical connector that mates with the proximal end of the Lead or the Lead extension external to the patient and connects with a Trial Therapy Disc (or the EIC Extension which likewise connects to the Trial Therapy Disc to provide an extension bridging the sterile field).
2020-04-21
Nalu Medical, Inc. - EIC
2020-04-21
Nalu Medical, Inc. - Limb Cuff (Black)
2020-04-21
Nalu Medical, Inc. - Limb Cuff, Large (Black)
2020-04-21
Nalu Medical, Inc. - Relief Belt (Black)
2020-04-21
Nalu Medical, Inc. - Straw Tunneler
2020-04-21
Nalu Medical, Inc. - Pocket Tunneler
2020-04-21
Extended Torque Wrench - A torque limited hex driver that is used to tighten the connector set screws and the Anchor.
2026-02-26
Nalu Medical, Inc. - Lead Blank, 50 cm
2020-04-21
Nalu Medical, Inc. - Spoonbill Needle (6"/15 cm)
2020-04-21
Nalu Medical, Inc. - Anchor
2020-04-21
Nalu Medical, Inc. - Lead Extension Kit (8)
2020-04-21
Nalu Medical, Inc. - Lead Blank, 50 cm
2019-09-23
Nalu Medical, Inc. - Limb Cuff, Large (Black)
2019-06-01
Nalu Medical, Inc. - Limb Cuff (Black)
2019-06-01
Nalu Medical, Inc. - Relief Belt (Black)
2019-06-01
Nalu Medical, Inc. - Adhesive Test Patch Pack
2019-06-01
Nalu Medical, Inc. - Adhesive Clip Pack (H300)
2019-06-01
Nalu Medical, Inc. - Adhesive Clip Pack (H100)
2019-06-01
Nalu Medical, Inc. - Adhesive Clip Pack (H200)
2019-06-01
Nalu Medical, Inc. - Stylet (straight, 30 cm)
2020-01-17
Nalu Medical, Inc. - Lead Kit (4 contact, 40 cm, Tined)
2020-01-17
Nalu Medical, Inc. - Nalu Neurostimulation Kit (Integrated, Single 4, 40 cm, Tined)
2020-01-17
Nalu Medical, Inc. - Lead Kit (4 contact, 25 cm, Tined)
2020-01-17
Nalu Medical, Inc. - Lead Extension Kit (4)
2020-01-17
Nalu Medical, Inc. - Nalu Neurostimulation Kit (Ported, Single 4)
2020-01-17
Nalu Medical, Inc. - Nalu Neurostimulation Kit (Integrated, Single 4, 25 cm, Tined)
2020-01-17
Nalu Medical, Inc. - Nalu Neurostimulation Kit (Integrated, Dual 8, 40 cm)
2019-06-01
Nalu Medical, Inc. - Trial Lead (8 contact, 60 cm)
2019-06-01
Nalu Medical, Inc. - Peripheral Nerve Stimulation Lead (8 contact, 60 cm)
2020-02-27
Nalu Medical, Inc. - Peripheral Nerve Stimulation Lead (8 contact, 40 cm)
2020-02-27
Nalu Medical, Inc. - Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm)
2020-02-27
Nalu Medical, Inc. - Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm)
2020-02-27
Nalu Medical, Inc. - Nalu Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm)
2020-02-27
Nalu Medical, Inc. - SCS Remote App (compatible with iOS)
2019-06-01
Nalu Medical, Inc. - Nalu Neurostimulation User's Kit
2019-06-01