Ampa One System
Ampa One System (AMPA-001) is a repetitive transcranial magnetic stimulation system. It produces non-invasive magnetic fields that induce electrical currents in brain tissue and target…
Ampa One System (AMPA-001) is a repetitive transcranial magnetic stimulation system. It produces non-invasive magnetic fields that induce electrical currents in brain tissue and target cerebral cortex regions.
The L Coil targets the left dorsolateral prefrontal cortex, and the M Coil targets the bilateral prefrontal cortex. The filing says both are used to treat adults with major depressive disorder who did not improve satisfactorily with prior antidepressant medication in the current episode.
Listed Item
The Ampa One System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday’s law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged 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 induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons.
Device Function and Details
The system includes two coils, a bridge box and cables, a tablet software interface, a support arm and neuronavigation cap. It requires a compatible pulse generator, and the filing names the MagVenture MagPro R30.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mastars Industries Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Yiwu Inwell Craft&Gift Co., Ltd. | Jin Hua | Zhejiang | Contract manufacturer | 7 |
| Shenzhen Yingchi Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Neuromodulatory Devices & Applications, United States |
|---|---|
| FDA product code | OBP |
| Device type | Transcranial Magnetic Stimulator |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5805 |
| 510(k) | K243319 |
| Record published | 2025-06-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMPA-001 | In distribution | |
| AMPA-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MagPro Accessories | Tonica Elektronik A/S | 31 |
| MagPro | Tonica Elektronik A/S | 18 |
| NeuroStar Advanced Therapy System | Neuronetics Inc. | 15 |
| Deep Transcranial Magnetic Stimulation (Dtms) System | Brainsway Ltd. | 10 |
| TrakStar Patient Data Management System Software | Neuronetics Inc. | 5 |
| NeuroStar System Software | Neuronetics Inc. | 4 |
| NeuroStar TMS Therapy System | Neuronetics Inc. | 4 |
| Ultimate rTMS | Shenzhen Yingzhi Technology Co., Ltd. | 4 |
| NeuroStar Head Support System, Domestic | Neuronetics Inc. | 3 |
| Saint | Magnus Medical Inc. | 3 |
| SenStar Treatment Link | Neuronetics Inc. | 2 |
| TMS Coil Cooler | Shenzhen Yingzhi Technology Co., Ltd. | 2 |
Showing 12 of 98. All products under Transcranial Magnetic Stimulator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251210 | 2025-06-27 |
| K243319 | 2025-02-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.