The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Ultra (therapeutic Ultrasound Device).
| Device ID | K895690 |
| 510k Number | K895690 |
| Device Name: | ULTRA (THERAPEUTIC ULTRASOUND DEVICE) |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Contact | R. J Gagne |
| Correspondent | R. J Gagne EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-22 |
| Decision Date | 1990-02-20 |