Ampa One System

Primary DI
00860011991205
Brand
Ampa One System
Company
Neuromodulatory Devices & Applications LLC
Model
AMPA-001
Device description
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.
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBPTranscranial Magnetic Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBPTranscranial Magnetic StimulatorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243319000Ampa One System (AMPA-001)Neuromodulatory Devices & Applications2025-02-13OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011991205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011991205008600119912058600119912050860011991205

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation systemAn assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2488257429mitchell.cook@ampahealth.com

Regulatory Flags#

DUNS number
118996575
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011991212Ampa One System AMPA-0012025-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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