The following data is part of a premarket notification filed by Omni Intl., Inc. with the FDA for Omni Stim Ii.
| Device ID | K813604 |
| 510k Number | K813604 |
| Device Name: | OMNI STIM II |
| Classification | Stimulator, Muscle, Powered |
| Applicant | OMNI INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-28 |
| Decision Date | 1982-03-08 |