Electromagnetic Stimulator, Pain Relief
FDA product code QPL · Class II (moderate risk) · 21 CFR 882.5890 · Neurology
Intended to apply a magnetic-field induced electrical current to treat pain.
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250309 | BTL-199QPL · Traditional | BTL Industries, Inc. | 08/07/2025SE |
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…QPL · Traditional | The Magstim Company Limited | 07/03/2025SE |
| K241785 | StarFormer (M008-3T)QPL · Traditional | Fotona D.O.O. | 03/27/2025SE |
| K233364 | Axon TherapyQPL · Traditional | Neuralace Medical, Inc. | 01/10/2024SE |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…QPL · Traditional | Tonica Elektronik A/S | 08/25/2023SE |
| K210021 | Axon TherapyQPL · Traditional | Neuralace Medical, Inc. | 06/11/2021SE |