Class Class II
Ampa One System (AMPA-001) (K243319)
Description
Ampa One System (AMPA-001) by Neuromodulatory Devices & Applications, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243319
Clearance Date2025-02-13
Clearance TypeTraditional
Product CodeOBP
Regulation Number882.5805
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243319
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ampa One System (AMPA-001) (K243319) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220819 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2022 |
| K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025 |
Trace the full predicate network for K243319
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.