510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130978Substantially Equivalent

Ztx Ultrasonic Diathermy Device

Zetroz, Inc., Trumbull CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130978 is the FDA 510(k) clearance record for ZTX ULTRASONIC DIATHERMY DEVICE, a class II device, cleared for Zetroz, Inc. on under FDA product code PFW (Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat). FDA's definition for product code PFW reads: "Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation". FDA records list one 510(k) clearance for Zetroz, Inc. As of , FDA records show no recalls naming K130978.

Clearance record

Decision date
Received
(211 days to decision)
Product code
PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5300
Device class
Class II
Review panel
Physical Medicine
Applicant
Zetroz, Inc. 56 Quarry Rd., Trumbull CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFW

Trailing 12 months
1 clearance under product code PFW in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PFW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260