QPL
6 FDA 510(k) clearances · Product code
185 daysmedian time to decision
280 days90th percentile
6clearances measured
FDA profile
- Official device name
- Electromagnetic Stimulator, Pain Relief
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5890
- Medical specialty
- Neurology
- FDA definition
- Intended to apply a magnetic-field induced electrical current to treat pain.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BTL-199 (K250309) | BTL Industries, Inc. | 2025-08-07 |
| Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) (K250286) | The Magstim Company Limited | 2025-07-03 |
| StarFormer (M008-3T) (K241785) | Fotona D.O.O. | 2025-03-27 |
| Axon Therapy (K233364) | Neuralace Medical, Inc. | 2024-01-10 |
| MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (K230014) | Tonica Elektronik A/S | 2023-08-25 |
| Axon Therapy (K210021) | Neuralace Medical, Inc. | 2021-06-11 |
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Every clearance here is in the API, with alerts when new ones post.