K072256 is an FDA 510(k) clearance for the HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL. 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 Hill Laboratories Co. (Frazer, US). The FDA issued a Cleared decision on March 12, 2008, 212 days after receiving the submission on August 13, 2007.
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 | K072256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2007 |
| Decision Date | March 12, 2008 |
| Days to Decision | 212 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. |