# K143531: Rapid Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Magstim Company Limited
- Decided: May 8, 2015 after 147 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN070003 (2008). 4 ancestors in all.
62 later devices descend from it; 7 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133408: Neurostar TMS Therapy System, Neuronetics (2014) Summary page 4.

## Most influential descendants
- K160309: Neurosoft TMS (2016), 46 descendants of its own
- K171967: MagVita TMS Therapy System (2017), 40 descendants of its own
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation (2018), 39 descendants of its own
- K193006: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (2020), 24 descendants of its own
- K212289: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (2022), 19 descendants of its own

## Recalls of this device
- Mar 23, 2020 · Class II · Z-1965-2020: It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
- Mar 23, 2020 · Class II · Z-1966-2020: It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
- Sep 28, 2017 · Class II · Z-1352-2018: Users manuals not supplied with 4800-00T US Rapid Therapy System

## Indications for use
The Rapid2 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/K143531
Methodology: https://510kreport.com/methodology