510(k) K222230
- Device
- NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System For Mental Health
- Applicant
- Neuronetics, Inc.
- 510(k) number
- K222230
- Product code
- OBP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-24
- Date received
- 2022-07-25
- Regulation
- 882.5805
- Classification name
- Transcranial Magnetic Stimulator
- 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#
- 3020848550
- 3003144120
- 3005545216
- 3039167582
- 3017496797
- 3012823347
- 3035374386
- 3029767018
- 9612389
- 3019055598
- 3003127839
- 3014251656
- 3010300912
- 3018708317
- 3005205657
- 8021774
- 3014680784
- 3006418479
- 3004824012
- 3029464335
- 3008881376
- 3007147067
- 3012352782
- 3005268307
Source Documents#
Other 510(k) Records For Product Code OBP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | 2026-05-22 |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | 2026-05-22 |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026-03-20 |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026-03-20 |
| K251653 | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | 2026-02-20 |
| K251391 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-11-07 |
| K250689 | CloudTMS Edge | Teleemg, LLC | 2025-09-14 |
| K251449 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-09-13 |
| K243700 | Apollo TMS Therapy System | Mag & More GmbH | 2025-09-04 |
| K243539 | Apollo TMS Therapy System | Mag & More GmbH | 2025-08-18 |
| K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025-08-11 |
| K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025-08-08 |
| K252032 | T65 (9016E061-) | Tonica Elektronik A/S | 2025-07-30 |
| K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025-06-27 |
| K243460 | Ultimate rTMS | Brain Ultimate, Inc. | 2025-04-17 |
Legacy Summary#
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FDA Review#
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