ZetrOZ Systems

FDA Device Registration & Listing · Trumbull, CT, US · Registration 3010765975

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010765975
FEI Number
3010765975
Entity Name
ZetrOZ Systems
City/State/Country
Trumbull, CT, US
Establishment Address
56 Quarry Rd, Trumbull, CT 06611, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Zetroz Systems (Owner Number: 10046288)
Owner / Operator Contact Address
56 Quarry Rd., Trumbull, CT 06611, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K260076
PMA Number
N/A

All Registered Proprietary Names

SAM 2 Long Duration Ultrasound Device sam 2 Long Duration Ultrasound Device for Home Use SAM X1 sam SAM 3 Multi-Hour Continuous Ultrasound Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2024-12-29
PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2020-03-16
PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2022-09-14
PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2014-02-28
PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2026-05-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zetroz Systems
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010765975. Last updated year: 2026. Please use registration number 3010765975 when referencing this establishment in official correspondence.
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