The following data is part of a premarket notification filed by Ito Co., Ltd. with the FDA for Us-100 Portable Ultrasound Therapy Unit.
| Device ID | K032793 |
| 510k Number | K032793 |
| Device Name: | US-100 PORTABLE ULTRASOUND THERAPY UNIT |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | ITO CO., LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey ITO CO., LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-09 |
| Decision Date | 2003-10-09 |
| Summary: | summary |