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…

Registry build 21.09.26

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.

3manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OBP
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

Regulatory record for Ampa One System
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

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Ampa One System
Catalogue number Size Status
AMPA-001 In distribution
AMPA-001 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer