# K211513: sam X1 Long Duration Ultrasound Device

- Pathway: 510(k) (Special)
- Applicant: ZetrOZ Systems, LLC
- Decided: Aug 18, 2021 after 96 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: 3 generations back to K120171 (2012). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191568: sam 2.0 Long Duration Ultrasound System, ZetrOZ Systems, LLC (2020) Summary page 4.

## Most influential descendants
- K233210: sam CS Long Duration Ultrasound Device (2023), 0 descendants of its own

## Indications for use
The sam X1 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation

Source page: https://510kreport.com/device/K211513
Methodology: https://510kreport.com/methodology