K112520 is an FDA 510(k) clearance for the US-101L, US-103S. 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. (Tokyo, JP). The FDA issued a Cleared decision on October 26, 2011, 56 days after receiving the submission on August 31, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300.
| 510(k) Number | K112520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2011 |
| Decision Date | October 26, 2011 |
| Days to Decision | 56 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 |