neuroqore.comNQ TMS for MDD (NQv1-MU-01)
Neuroqore, Inc.
NEUROQORE, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| NEUROQORE, INC. | 5 | N | 2027-01-01 | 201 Jason Way Mountain View CA US 94043 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860012355402 | NQ TMS - The NQ TMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode. | 949-397-1333 | mt@neuroqore.com |
| 00860012355419 | NQ TMS Applicator Arm - Applicator Arm: It is used to hold and position an Applicator around patient’s head to target TMS stimulation to a specific region of interest in patient’s cortex. | 949-397-1333 | mt@neuroqore.com |
| 00860012355426 | NQ TMS Applicator - Coil or Applicator: It is used with a Transcranial Magnetic Stimulator (TMS) to generate a magnetic field that in turn delivers electrical stimulation to the patient’s cortex. It is positioned to target a specific stimulation region of interest. | 949-397-1333 | mt@neuroqore.com |
| 00860012355433 | NQ TMS Coil Cooler - Cooling Unit: It is used to ensure that a TMS Applicator does not overheat during TMS treatment, thus preventing risk of burn to the user or the patient. | 949-397-1333 | mt@neuroqore.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 353373 | 1477773197 | K232688 | NQ TMS for MDD (NQv1-MU-01) | OBP | 2023-12-29 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OBP | 1 | 2023-12-29 |
PMN#
GUDID#
NQ TMS Applicator Arm - Applicator Arm: It is used to hold and position an Applicator around patient’s head to target TMS stimulation to a specific region of interest in patient’s cortex.
2025-08-06
NQ TMS Applicator - Coil or Applicator: It is used with a Transcranial Magnetic Stimulator (TMS) to generate a magnetic field that in turn delivers electrical stimulation to the patient’s cortex. It is positioned to target a specific stimulation region of interest.
2025-08-06
NQ TMS Coil Cooler - Cooling Unit: It is used to ensure that a TMS Applicator does not overheat during TMS treatment, thus preventing risk of burn to the user or the patient.
2025-08-06
NQ TMS - The NQ TMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
2024-10-08