# K233631: ZapStim Controller Application (Z1023)

- Pathway: 510(k) (Traditional)
- Applicant: Revital Lab, Inc.
- Decided: Feb 9, 2024 after 88 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN070003 (2008). 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)
- K173441: Neurosoft TMS (also CloudTMS), Teleemg, LLC (2017) Summary page 4.

## Indications for use
ZapStim Controller Application is intended for use with the Neurosoft TMS system and is indicated for use in delivering the FDA cleared treatment protocol for treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode.

Source page: https://510kreport.com/device/K233631
Methodology: https://510kreport.com/methodology