K250286 is an FDA 510(k) clearance for the Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1). This device is classified as a Electromagnetic Stimulator, Pain Relief (Class II - Special Controls, product code QPL).
Submitted by The Magstim Company Limited (Carmarthenshire, GB). The FDA issued a Cleared decision on July 3, 2025, 153 days after receiving the submission on January 31, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5890. Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain..
| 510(k) Number | K250286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2025 |
| Decision Date | July 03, 2025 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | QPL - Electromagnetic Stimulator, Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain. |