# K191568: sam 2.0 Long Duration Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: ZetrOZ Systems, LLC
- Decided: Mar 6, 2020 after 267 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: 2 generations back to K120171 (2012). 2 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130978: ZTX Ultrasonic Diathermy Device, Zetroz, Inc. (2013) Summary page 4.

## Most influential descendants
- K223019: sam 2.0 Long Ultrasound Device (2023), 1 descendant of its own
- K222098: ManaSport+ (2023), 1 descendant of its own
- K211513: sam X1 Long Duration Ultrasound Device (2021), 1 descendant of its own
- K260076: SAM 3.0 Multi-Hour Continuous Ultrasound Device (2026), 0 descendants of its own
- K240788: Ultrasound Stimulator (2025), 0 descendants of its own

## Indications for use
The sam 2.0 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/K191568
Methodology: https://510kreport.com/methodology