# K230472: Sonopuls 190

- Pathway: 510(k) (Traditional)
- Applicant: Enraf-Nonius, B.V.
- Decided: Oct 24, 2023 after 244 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
Longest line of descent: 4 generations back to K984142 (1999). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202788: Sonomed IV, Sonomed V, Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto (2021) Summary page 5.

## Most influential descendants
- K241099: Plasonic (Plasonic) (2024), 2 descendants of its own
- K260397: SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (2026), 0 descendants of its own
- K251334: New Doublo 2.0 (2025), 0 descendants of its own

## Indications for use
Therapeutic Ultrasound is indicated for: * Pain Relief * Reduction of muscle spasms * Localized increase in blood flow * Increase range of motion of contracted joints using heat and stretch techniques

Source page: https://510kreport.com/device/K230472
Methodology: https://510kreport.com/methodology