The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Isotron 220.
| Device ID | K900823 |
| 510k Number | K900823 |
| Device Name: | ISOTRON 220 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Contact | Ray J Gagne |
| Correspondent | Ray J Gagne EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-20 |
| Decision Date | 1990-03-26 |