K032793 is an FDA 510(k) clearance for the US-100 PORTABLE ULTRASOUND THERAPY UNIT. This device is classified as a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMI).
Submitted by Ito Co., Ltd. (Brookeville, US). The FDA issued a Cleared decision on October 9, 2003, 30 days after receiving the submission on September 9, 2003.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300.
| 510(k) Number | K032793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2003 |
| Decision Date | October 09, 2003 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMI - Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5300 |