FDA.reportPublic FDA data

NEUROMODULATORY DEVICES & APPLICATIONS (NMDA), INC

Matched from indexed company URL: Neuromodulatory Devices & Applications

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30391675823039167582NEUROMODULATORY DEVICES & APPLICATIONS (NMDA), INC1N2026-01-01501 W Broadway Ste 1025 San Diego CA US 92101

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860011991205Ampa One System - The Ampa One System is a computerized, electromechanical medical device that produces and deliversnon-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of thecerebral cortex. The system contains two different coils for targeting different regions of the brain. The LCoil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to targetthe bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat MajorDepressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement fromprior antidepressant medication in the current episode.Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neuraltissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current aregenerated with a circuit containing a capacitor connected to the stimulating coil. With the capacitorcharged to a certain level, the conducting state will cause the discharging of the capacitor through the coil.A magnetic field is generated proportional to this current. The rapid change in the magnetic field inducesa current in conducting materials e.g. the body tissue. If the current induced in the human body is ofsufficient amplitude and duration, it will excite neurons.2488257429mitchell.cook@ampahealth.com
00860011991212Ampa One System - The Ampa One System is a computerized, electromechanical medical device that produces and deliversnon-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of thecerebral cortex. The system contains two different coils for targeting different regions of the brain. The LCoil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to targetthe bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat MajorDepressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement fromprior antidepressant medication in the current episode.Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neuraltissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current aregenerated with a circuit containing a capacitor connected to the stimulating coil. With the capacitorcharged to a certain level, the conducting state will cause the discharging of the capacitor through the coil.A magnetic field is generated proportional to this current. The rapid change in the magnetic field inducesa current in conducting materials e.g. the body tissue. If the current induced in the human body is ofsufficient amplitude and duration, it will excite neurons.2488257429mitchell.cook@ampahealth.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3409781118946902K251210Ampa One System (AMPA-001)OBP2025-06-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBP12025-06-27

PMN#

GUDID#

Ampa One System - The Ampa One System is a computerized, electromechanical medical device that produces and deliversnon-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of thecerebral cortex. The system contains two different coils for targeting different regions of the brain. The LCoil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to targetthe bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat MajorDepressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement fromprior antidepressant medication in the current episode.Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neuraltissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current aregenerated with a circuit containing a capacitor connected to the stimulating coil. With the capacitorcharged to a certain level, the conducting state will cause the discharging of the capacitor through the coil.A magnetic field is generated proportional to this current. The rapid change in the magnetic field inducesa current in conducting materials e.g. the body tissue. If the current induced in the human body is ofsufficient amplitude and duration, it will excite neurons.

Neuromodulatory Devices & Applications LLC

2025-07-28

Ampa One System - The Ampa One System is a computerized, electromechanical medical device that produces and deliversnon-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of thecerebral cortex. The system contains two different coils for targeting different regions of the brain. The LCoil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to targetthe bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat MajorDepressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement fromprior antidepressant medication in the current episode.Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neuraltissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current aregenerated with a circuit containing a capacitor connected to the stimulating coil. With the capacitorcharged to a certain level, the conducting state will cause the discharging of the capacitor through the coil.A magnetic field is generated proportional to this current. The rapid change in the magnetic field inducesa current in conducting materials e.g. the body tissue. If the current induced in the human body is ofsufficient amplitude and duration, it will excite neurons.

Neuromodulatory Devices & Applications LLC

2025-06-27