# K192823: Mega-TMS

- Pathway: 510(k) (Traditional)
- Applicant: Soterix Medical, Inc.
- Decided: Aug 13, 2021 after 681 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K905059 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060847: Magstim 200-2, Magstim Company Us, LLC (2006) Summary page 4.
- K091940: Magpro, Models R30 with Magoption, X100, X100 with Magoption, Tonica Elektronik A/S (2010) Summary page 4.

## Indications for use
Stimulation of peripheral nerves for diagnostic purposes.

Source page: https://510kreport.com/device/K192823
Methodology: https://510kreport.com/methodology