# K984199: Exonix

- Pathway: 510(k) (Traditional)
- Applicant: Fibra Sonics, Inc.
- Decided: Feb 17, 1999 after 85 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.
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 Fibra Sonics Exonix Ultrasound device is used to produce therapeutic deep heat for the following conditions: 1. Temporary relief of pain 2. Muscle Spasms 3. Joint contractures

Source page: https://510kreport.com/device/K984199
Methodology: https://510kreport.com/methodology