The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Isotron Iii.
| Device ID | K941815 |
| 510k Number | K941815 |
| Device Name: | ISOTRON III |
| Classification | Interferential Current Therapy |
| Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Contact | John R Mumford |
| Correspondent | John R Mumford EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Product Code | LIH |
| Subsequent Product Code | GZK |
| Subsequent Product Code | IPF |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-12 |
| Decision Date | 1995-05-03 |