K230014 is an FDA 510(k) clearance for the MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption. This device is classified as a Electromagnetic Stimulator, Pain Relief (Class II - Special Controls, product code QPL).
Submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on August 25, 2023, 234 days after receiving the submission on January 3, 2023.
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 | K230014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2023 |
| Decision Date | August 25, 2023 |
| Days to Decision | 234 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. |