510(k) K162935
- Device
- Rapid2 Therapy System
- Applicant
- MAGSTIM COMPANY LTD.
- 510(k) number
- K162935
- Product code
- OBP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-10
- Date received
- 2016-10-20
- Regulation
- 882.5805
- Classification name
- Transcranial Magnetic Stimulator
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kevyn Beard
- Address
- Spring Gardens Whitland GB SA340HR SA340HR
FDA Registration Numbers#
- 3020848550
- 3004824012
- 3005545216
- 3003144120
- 9612389
- 3006418479
- 3029767018
- 3029464335
- 3017496797
- 3014680784
- 3007147067
- 3014251656
- 3012352782
- 3010300912
- 3045753434
- 3012823347
- 8021774
- 3005268307
- 3019055598
- 3003127839
- 3008881376
- 3035374386
- 3018708317
- 3005205657
- 3031980484
- 3039167582
Source Documents#
Other 510(k) Records For Product Code OBP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | Fidelity BioPharma Co. | 2026-09-06 |
| K260691 | BTL-699 | BTL Industries, Inc. | 2026-08-23 |
| K261228 | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | 2026-08-14 |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | 2026-05-22 |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | 2026-05-22 |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026-03-20 |
| K253098 | 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 |
Legacy Summary#
summary
FDA Review#
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