# K250689: CloudTMS Edge

- Pathway: 510(k) (Traditional)
- Applicant: Teleemg, LLC
- Decided: Sep 14, 2025 after 192 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: 8 generations back to DEN070003 (2008). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S (2018) Summary page 5.
- K173441: Neurosoft TMS (also CloudTMS), Teleemg, LLC (2017) Summary page 5.

## Indications for use
The CloudTMS Edge system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.

Source page: https://510kreport.com/device/K250689
Methodology: https://510kreport.com/methodology