QPL
- Product code
- QPL
- Device name
- Electromagnetic Stimulator, Pain Relief
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5890
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 6 (all years; only the last 3 years are listed here)
FDA classification definition
Intended to apply a magnetic-field induced electrical current to treat pain.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250309 | 2025-08-07 | BTL Industries, Inc. | BTL-199 | |
| K250286 | 2025-07-03 | The Magstim Company Limited | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim… | FDA |
| K241785 | 2025-03-27 | Fotona D.O.O. | StarFormer (M008-3T) | |
| K233364 | 2024-01-10 | Neuralace Medical, Inc. | Axon Therapy |
Official FDA classification page: QPL
Classification and pathway per current FDA publications. Data from openFDA (CC0).