FDA Product Code
FDA Product Code QCI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5802
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243459 | Ultimate rTMS for OCD (M-series) | Brain Ultimate, Inc. | 2025-04-17 | Traditional | PDF ↗ |
| K230657 | BTL-99-OC | BTL Industries, Inc. | 2024-02-01 | Traditional | PDF ↗ |
| K233742 | CloudTMS Edge for OCD | Teleemg, LLC | 2023-12-22 | Special | PDF ↗ |
| K231350 | OCD MT Cap (85-00397-000) | Neuronetics | 2023-06-08 | Special | PDF ↗ |
| K221129 | CloudTMS for OCD | Teleemg, LLC | 2023-03-10 | Traditional | PDF ↗ |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar | Neuronetics, Inc. | 2022-05-06 | Traditional | PDF ↗ |
| K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020-08-09 | Traditional | PDF ↗ |
| K183303 | Brainsway Deep TMS System | Brainsway , Ltd. | 2019-03-08 | Traditional | PDF ↗ |
| DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | Brainways , Ltd. | 2018-08-17 | Direct | — |
Product code QCI · Class II · Neurology. Data: openFDA.