# K240788: Ultrasound Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Jkh Health Co., Ltd.
- Decided: Jun 4, 2025 after 439 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 K120171 (2012). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222098: ManaSport+, Manamed, Inc. (2023) Summary page 5.
- K191568: sam 2.0 Long Duration Ultrasound System, ZetrOZ Systems, LLC (2020) Summary page 5.

## Indications for use
Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. 2. Pain relief, muscle spasms, and joint contractures. 3. Relief of pain, muscle spasms, and joint contractures that may be associated with: » Adhesive capsulitis, * Bursitis with slight calcification, » Myositis, * Soft tissue injuries, and » Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: » Capsular tightness, and » Capsular scarring. 5. Localized increase in blood flow. 6. Increased range of motion of contracted joint using heat and stretch techniques.

Source page: https://510kreport.com/device/K240788
Methodology: https://510kreport.com/methodology