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510(k) K251210

Ampa One System (AMPA-001) by Neuromodulatory Devices & Applications — Product Code OBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2025
Date Received
April 18, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulator
Device Class
Class II
Regulation Number
882.5805
Review Panel
NE
Submission Type

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.

Other clearances by Neuromodulatory Devices & Applications

  • K243319 — Ampa One System (AMPA-001) (February 13, 2025)

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  • K251125 — MagVenture TMS Therapy System (August 11, 2025)
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  • K252032 — T65 (9016E061-) (July 30, 2025)
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