The following data is part of a premarket notification filed by U.s. Medical Corp. with the FDA for Pulsed Galvanic Stimulator, 450-dynamax.
| Device ID | K801053 |
| 510k Number | K801053 |
| Device Name: | PULSED GALVANIC STIMULATOR, 450-DYNAMAX |
| Classification | Stimulator, Muscle, Powered |
| Applicant | U.S. MEDICAL CORP. 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 | 1980-05-05 |
| Decision Date | 1980-06-04 |