510(k) K231350
- Device
- OCD MT Cap (85-00397-000)
- Applicant
- Neuronetics
- 510(k) number
- K231350
- Product code
- QCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-08
- Date received
- 2023-05-09
- Regulation
- 882.5802
- Classification name
- Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amanda Pentecost
- Address
- 3222 Phoenixville Pike Malvern PA US 19355 19355
FDA Registration Numbers#
- 3012352782
- 3004824012
- 3006418479
- 3029767018
- 3012823347
- 3020848550
- 3007147067
- 3005545216
- 3010300912
- 3014680784
- 3003127839
- 3003144120
- 3005268307
- 8021774
Source Documents#
Other 510(k) Records For Product Code QCI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243459 | Ultimate rTMS for OCD (M-series) | Brain Ultimate, Inc. | 2025-04-17 |
| K230657 | BTL-99-OC | BTL Industries, Inc. | 2024-02-01 |
| K233742 | CloudTMS Edge for OCD | Teleemg, LLC | 2023-12-22 |
| K221129 | CloudTMS for OCD | Teleemg, LLC | 2023-03-10 |
| 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 |
| K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020-08-09 |
| K183303 | Brainsway Deep TMS System | Brainsway , Ltd. | 2019-03-08 |
| DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | Brainways , Ltd. | 2018-08-17 |