The following data is part of a premarket notification filed by Henley Intl. with the FDA for Ems 8100.
| Device ID | K895301 |
| 510k Number | K895301 |
| Device Name: | EMS 8100 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Ernest J Henley |
| Correspondent | Ernest J Henley HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-25 |
| Decision Date | 1990-02-20 |