The following data is part of a premarket notification filed by Electro-med Health Industries, Inc. with the FDA for Egs #300 Battery Oper. Porta. Muscle Sti.
| Device ID | K802107 |
| 510k Number | K802107 |
| Device Name: | EGS #300 BATTERY OPER. PORTA. MUSCLE STI |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ELECTRO-MED HEALTH INDUSTRIES, 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 | 1980-09-03 |
| Decision Date | 1980-10-03 |