510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211513Substantially Equivalent

sam X1 Long Duration Ultrasound Device

ZetrOZ Systems, Trumbull CT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211513 is the FDA 510(k) clearance record for sam X1 Long Duration Ultrasound Device, a class II device, cleared for ZetrOZ Systems, LLC 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 5 510(k) clearances for ZetrOZ Systems, LLC, from to . As of , FDA records show no recalls naming K211513.

Clearance record

Decision date
Received
(96 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 Systems, LLC 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