510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PFWClass II

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

21 CFR 890.5300 / Physical Medicine
FDA source (opens on fda.gov)

PFW is the FDA product code for Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat, a class II device type, regulated under 21 CFR 890.5300. FDA's definition for this code reads: "Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PFW
Device name
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
FDA definition
Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
Regulation
21 CFR 890.5300
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
0

Clearances, product code PFW

By decision year
9 clearances under product code PFW with a decision year between 2008 and 2026, 2008 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PFW by decision year
YearClearances
20082
20131
20201
20211
20221
20232
20261

Applicants with the most clearances

Product code PFW
Applicants holding the most 510(k) clearances under product code PFW
ApplicantClearances
ZetrOZ Systems5
Hill Laboratories1
Nano Vibronix, Ltd.1
Nanovibronix, Ltd.1
Zetroz, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code