Ampa One System

GUDID 00860011991205

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.

Neuromodulatory Devices & Applications LLC

Magnetic neural stimulation system

• Primary Device ID: 00860011991205
• NIH Device Record Key: e9492499-893d-4b1f-803e-ff2371f11b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ampa One System
• Version Model Number: AMPA-001
• Company DUNS: 118996575
• Company Name: Neuromodulatory Devices & Applications LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com
• Phone: 2488257429
• Email: mitchell.cook@ampahealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011991205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243319

FDA Product Code

• OBP: Transcranial Magnetic Stimulator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-07
• Device Publish Date: 2025-06-27