K203710 is an FDA 510(k) clearance for the Storz Medical MAGNETOLITH Muscle Stimulator. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Storz Medical AG (Tagerwilen, CH). The FDA issued a Cleared decision on May 3, 2021, 133 days after receiving the submission on December 21, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K203710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2020 |
| Decision Date | May 03, 2021 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |