The following data is part of a premarket notification filed by Storz Medical Ag with the FDA for Storz Medical Magnetolith Muscle Stimulator.
| Device ID | K203710 |
| 510k Number | K203710 |
| Device Name: | Storz Medical MAGNETOLITH Muscle Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Storz Medical AG Lohstampfestrasse 8 Tägerwilen, CH Ch-8274 |
| Contact | Pavel Novak |
| Correspondent | Michael Dayton Biomed Research, Inc. 3959 Van Dyke Road Suite 245 Lutz, FL 33558 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2021-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630039101350 | K203710 | 000 |