K130978 is an FDA 510(k) clearance for the ZTX ULTRASONIC DIATHERMY DEVICE. This device is classified as a Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code PFW).
Submitted by Zetroz, Inc. (Trumbull, US). The FDA issued a Cleared decision on November 6, 2013, 211 days after receiving the submission on April 9, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300. Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation..
| 510(k) Number | K130978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2013 |
| Decision Date | November 06, 2013 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | PFW — Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5300 |
| Definition | Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation. |