Class Class II
T65 (9016E061-) (K252032)
Description
T65 (9016E061-) by Tonica Elektronik A/S, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252032
Clearance Date2025-07-30
Clearance TypeSpecial
Product CodeOBP
Regulation Number882.5805
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252032
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. T65 (9016E061-) (K252032) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 |
| K171481 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 |
| K150641 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2015 |
Trace the full predicate network for K252032
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.