# K020119: Vectorsonic, Model VU-200

- Pathway: 510(k) (Traditional)
- Applicant: Metron Medical Australia, Pty, Ltd.
- Decided: Jul 22, 2002 after 189 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The indications for use for the interferential therapy are: 1. Relaxation of muscle spasm; 2. Prevention or retardation of disuse atrophy; 3. Increasing local blood flow; 4. Muscle re-education; 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6. Maintaining or increasing range of motion. The indications for use for the ultrasound therapy are: 1. Relief or reduction of pain; 2. Reduction of muscle spasm; 3. Joint contracture; and 4. Local increase in circulation. The indication for use for the combined therapy is: 1. Reduction of muscle spasm.

Source page: https://510kreport.com/device/K020119
Methodology: https://510kreport.com/methodology