# K260076: SAM 3.0 Multi-Hour Continuous Ultrasound Device

- Pathway: 510(k) (Special)
- Applicant: ZetrOZ Systems, LLC
- Decided: Apr 28, 2026 after 106 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)
- K223019: sam 2.0 Long Ultrasound Device, ZetrOZ Systems, LLC (2023) Summary page 5.

## Indications for use
The SAM 3.0 Multi-Hour Continuous 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, the local increase in circulation, and the relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy).

Source page: https://510kreport.com/device/K260076
Methodology: https://510kreport.com/methodology