# K130978: ZTX Ultrasonic Diathermy Device

- Pathway: 510(k) (Traditional)
- Applicant: Zetroz, Inc.
- Decided: Nov 6, 2013 after 211 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: 1 generation back to K120171 (2012). 1 ancestor in all.
7 later devices descend from it; 1 cites 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)
- K120171: Accusonic Advantage, Metron Medical Australia, Pty, Ltd. (2012) Summary page 2.

## Most influential descendants
- K191568: sam 2.0 Long Duration Ultrasound System (2020), 6 descendants of its own
- 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

## Indications for use
The ZTX Ultrasonic Diathermy Device is intended 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. The ZTX Ultrasonic Diathermy Device is a prescription use device. The ZTX Device should only be administered and monitored by a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K130978
Methodology: https://510kreport.com/methodology