FDA Product Code PFW: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation.
Leading manufacturers include ZetrOZ Systems, LLC and Nanovibronix, Inc..
FDA 510(k) Cleared Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Devices (Product Code PFW)
About Product Code PFW - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PFW since 2008, with 9 receiving FDA clearance (average review time: 169 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under PFW have taken an average of 106 days to reach a decision - down from 177 days historically, suggesting improved FDA processing for this classification.
PFW devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →