K022846 is an FDA 510(k) clearance for the SW-180 SHORTWAVE THERAPY UNIT. This device is classified as a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMJ).
Submitted by Ito Co., Ltd. (Brookeville, US). The FDA issued a Cleared decision on January 28, 2003, 154 days after receiving the submission on August 27, 2002.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K022846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2002 |
| Decision Date | January 28, 2003 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMJ - Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |