K243319 is an FDA 510(k) clearance for the Ampa One System (AMPA-001). This device is classified as a Transcranial Magnetic Stimulator (Class II - Special Controls, product code OBP).
Submitted by Neuromodulatory Devices & Applications (San Diego, US). The FDA issued a Cleared decision on February 13, 2025, 113 days after receiving the submission on October 23, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5805. A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder..
| 510(k) Number | K243319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2024 |
| Decision Date | February 13, 2025 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OBP - Transcranial Magnetic Stimulator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5805 |
| Definition | A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder. |