# K233210: sam CS Long Duration Ultrasound Device

- Pathway: 510(k) (Special)
- Applicant: ZetrOZ Systems, LLC
- Decided: Oct 25, 2023 after 27 days
- Product code: PFW (Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K120171 (2012). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211513: sam X1 Long Duration Ultrasound Device, ZetrOZ Systems, LLC (2021) Summary page 5.

## Indications for use
The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.

Source page: https://510kreport.com/device/K233210
Methodology: https://510kreport.com/methodology