Product code QPL
- Device name
- Electromagnetic Stimulator, Pain Relief
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5890
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Intended to apply a magnetic-field induced electrical current to treat pain.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250309 | BTL-199 | BTL Industries, Inc. | 2025-08-07 |
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | The Magstim Company Limited | 2025-07-03 |
| K241785 | StarFormer (M008-3T) | Fotona D.O.O. | 2025-03-27 |
| K233364 | Axon Therapy | Neuralace Medical, Inc. | 2024-01-10 |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | Tonica Elektronik A/S | 2023-08-25 |
| K210021 | Axon Therapy | Neuralace Medical, Inc. | 2021-06-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03830054238138 | QuantumStar, StarFormer | FOTONA d.o.o. | 2025-06-12 |
| B108899PO11C1ENUS0150 | EMSCULPT NEO | BTL INDUSTRIES LIMITED | 2024-09-23 |
| 03830054237728 | StarFormer | FOTONA d.o.o. | 2024-07-30 |
| 00860009424708 | CS6101 Interferential Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424869 | CS1304A HVG Leads | Control Solutions LLC | 2023-03-20 |
| 00860009424852 | CS3201-TL2 Interferential Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424845 | CS6101-3-K01 Interferential Kit | Control Solutions LLC | 2023-03-20 |
| 00860009424838 | CS6101-3 Interferential Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424821 | AC Power Adapter for CS6102 Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424814 | AC Power Adapter for CS6101 Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424807 | CS3101-TL2 Interferential Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424784 | Leadwire Set for CS6102 Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424777 | Leadwire Set for CS6101 Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424760 | CS6101-2 Interferential Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424753 | High Voltage Galvanic Stimulator Kit | Control Solutions LLC | 2023-03-20 |
| 00860009424746 | High Voltage Galvanic Stimulator Kit | Control Solutions LLC | 2023-03-20 |
| 00860009424739 | High Voltage Galvanic Stimulator | Control Solutions LLC | 2023-03-20 |
| 00860009424722 | CS6101 Interferential Kit | Control Solutions LLC | 2023-03-20 |
| 00860009424715 | CS6101 Interferential Kit | Control Solutions LLC | 2023-03-20 |
| 00860009424791 | CS6101-1 Interferential Stimulator | Control Solutions LLC | 2023-03-20 |
| 05713484020307 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484020239 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484020178 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484020093 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484020024 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484010032 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484010025 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484010018 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05060229530479 | Magstim Rapid² Power Supply Dual Module | THE MAGSTIM COMPANY LIMITED | 2016-09-23 |
| 05060229530455 | Magstim Rapid² Power Supply Single Module | THE MAGSTIM COMPANY LIMITED | 2016-09-23 |