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, Hill Laboratories Co. and Nano Vibronix , Ltd..
9
Total
9
Cleared
169d
Avg days
2008
Since
Declining activity -
1 submissions in the last 2 years
vs 3 in the prior period
Review times improving: avg
106d
recently vs 177d historically
FDA 510(k) Cleared Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Devices (Product Code PFW)
9 devices
Cleared
Apr 28, 2026
SAM 3.0 Multi-Hour Continuous Ultrasound Device
ZetrOZ Systems, LLC
Physical Medicine
106d
Cleared
Oct 25, 2023
sam CS Long Duration Ultrasound Device
ZetrOZ Systems, LLC
Physical Medicine
27d
Cleared
Jun 23, 2023
sam 2.0 Long Ultrasound Device
ZetrOZ Systems, LLC
Physical Medicine
267d
Cleared
Nov 23, 2022
PainShield MD PLUS
Nanovibronix, Inc.
Physical Medicine
210d
Cleared
Aug 18, 2021
sam X1 Long Duration Ultrasound Device
ZetrOZ Systems, LLC
Physical Medicine
96d
Cleared
Mar 06, 2020
sam 2.0 Long Duration Ultrasound System
ZetrOZ Systems, LLC
Physical Medicine
267d
Cleared
Nov 06, 2013
ZTX ULTRASONIC DIATHERMY DEVICE
Zetroz, Inc.
Physical Medicine
211d
Cleared
Aug 22, 2008
PAINSHIELD MD
Nano Vibronix , Ltd.
Physical Medicine
128d
Cleared
Mar 12, 2008
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
Hill Laboratories Co.
Physical Medicine
212d
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 510(k) Review Time - PFW Product Code
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 →