The following data is part of a premarket notification filed by Corleone Intl. Traders, Inc. with the FDA for Fittronic.
| Device ID | K861796 |
| 510k Number | K861796 |
| Device Name: | FITTRONIC |
| Classification | Stimulator, Muscle, Powered |
| Applicant | CORLEONE INTL. TRADERS, INC. P.O. BOX 3417 5617 HOLLYWOOD BOULEVARD, #101 Los Angeles, CA 90028 |
| Contact | Harry H Kazakian |
| Correspondent | Harry H Kazakian CORLEONE INTL. TRADERS, INC. P.O. BOX 3417 5617 HOLLYWOOD BOULEVARD, #101 Los Angeles, CA 90028 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-09 |
| Decision Date | 1986-06-25 |