Company ยท US
ZetrOZ Systems, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2026 | K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device ZetrOZ Systems, LLC | PFW |
| Oct 25, 2023 | K233210 | sam CS Long Duration Ultrasound Device ZetrOZ Systems, LLC | PFW |
| Jun 23, 2023 | K223019 | sam 2.0 Long Ultrasound Device ZetrOZ Systems, LLC | PFW |
| Aug 18, 2021 | K211513 | sam X1 Long Duration Ultrasound Device ZetrOZ Systems, LLC | PFW |
| Mar 6, 2020 | K191568 | sam 2.0 Long Duration Ultrasound System ZetrOZ Systems, LLC | PFW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||