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510(k) K191568

Device
Sam 2.0 Long Duration Ultrasound System
Applicant
ZetrOZ Systems, LLC
510(k) number
K191568
Product code
PFW  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-06
Date received
2019-06-13
Regulation
890.5300
Classification name
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sabrina Lewis
Address
56 Quarry Rd. Trumbull CT US 06611 06611

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PFW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC2026-04-28
K233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLC2023-10-25
K223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC2023-06-23
K221210PainShield MD PLUSNanovibronix, Inc.2022-11-23
K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC2021-08-18
K130978ZTX ULTRASONIC DIATHERMY DEVICEZetroz, Inc.2013-11-06
K081075PAINSHIELD MDNano Vibronix , Ltd.2008-08-22
K072256HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODELHill Laboratories Co.2008-03-12

Legacy Summary#

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FDA Review#

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