The following data is part of a premarket notification filed by Leo Unlimited, Inc. with the FDA for Cosmodyn-s Interferential Muscle Stim.
| Device ID | K833945 |
| 510k Number | K833945 |
| Device Name: | COSMODYN-S INTERFERENTIAL MUSCLE STIM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | LEO UNLIMITED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-15 |
| Decision Date | 1983-12-23 |