# K120171: Accusonic Advantage

- Pathway: 510(k) (Special)
- Applicant: Metron Medical Australia, Pty, Ltd.
- Decided: May 4, 2012 after 105 days
- Product code: IMI (Ultrasonic Diathermy 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
No predicates in its family tree.
8 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130978: ZTX Ultrasonic Diathermy Device (2013), 7 descendants of its own
- 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

## Indications for use
The indications for use are: 1. Relief or reduction of pain; 2. Reduction of muscle spasm; 3. Joint contracture; and 4. Local increase in circulation.

Source page: https://510kreport.com/device/K120171
Methodology: https://510kreport.com/methodology