The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Ultra V Therapeutic Ultrasound.
| Device ID | K001166 |
| 510k Number | K001166 |
| Device Name: | ULTRA V THERAPEUTIC ULTRASOUND |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Contact | Cameron Mahon |
| Correspondent | Cameron Mahon EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-07-07 |
| Summary: | summary |