# K202788: Sonomed IV, Sonomed V

- Pathway: 510(k) (Traditional)
- Applicant: Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto
- Decided: Dec 23, 2021 after 457 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: 3 generations back to K984142 (1999). 3 ancestors in all.
4 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)
- K130888: Sonopulse/ Sonopulse Iii, Ibramed- Industria Brazileria DE Equipamentos Medi (2014) Summary page 4.

## Most influential descendants
- K230472: Sonopuls 190 (2023), 3 descendants of its own
- 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 - 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/K202788
Methodology: https://510kreport.com/methodology