# K202537: ALTMS Magnetic Stimulation Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Remed Co., Ltd.
- Decided: Nov 26, 2021 after 451 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: 5 generations back to DEN070003 (2008). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143531: Rapid Therapy System, Magstim Company Limited (2015) Summary page 4.

## Most influential descendants
- K220625: ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System (2022), 1 descendant of its own
- K251653: SPRY TMS Therapy System (0550) (2026), 0 descendants of its own

## Indications for use
ALTMS Magnetic Stimulation Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Source page: https://510kreport.com/device/K202537
Methodology: https://510kreport.com/methodology