Data / Medical devices / United States / ZetrOZ Systems
ZetrOZ Systems: FDA-registered device maker in Trumbull, CT, United States, 5 510(k) clearances
ZetrOZ Systems is registered with the FDA (registration 3010765975) in Trumbull, CT, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated April 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010765975
- Address
- 56 Quarry Rd, Trumbull, CT, United States, 06611
- Owner or operator
- Zetroz Systems (10046288)
- Roles
- Manufacturer
- First device listed
- February 28, 2014
- Registered through
- 2026
- Brand names listed
- SAM 2 Long Duration Ultrasound Device, SAM 3 Multi-Hour Continuous Ultrasound Device, SAM X1, sam, sam 2 Long Duration Ultrasound Device for Home Use
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | PFW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 28, 2026 | K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | PFW | Substantially Equivalent | ZetrOZ Systems, LLC | accessdata.fda.gov |
| June 23, 2023 | K223019 | sam 2.0 Long Ultrasound Device | PFW | Substantially Equivalent | ZetrOZ Systems, LLC | accessdata.fda.gov |
| August 18, 2021 | K211513 | sam X1 Long Duration Ultrasound Device | PFW | Substantially Equivalent | ZetrOZ Systems, LLC | accessdata.fda.gov |
| March 6, 2020 | K191568 | sam 2.0 Long Duration Ultrasound System | PFW | Substantially Equivalent | ZetrOZ Systems, LLC | accessdata.fda.gov |
| November 6, 2013 | K130978 | ZTX ULTRASONIC DIATHERMY DEVICE | PFW | Substantially Equivalent | Zetroz, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.