# K244041: Ultrasound Therapy Workstation (XMS-UET2)

- Pathway: 510(k) (Traditional)
- Applicant: Xemis Medical Technology (Shenzhen) Co., Ltd.
- Decided: Oct 7, 2025 after 281 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
Longest line of descent: 3 generations back to K945509 (1995). 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)
- K150436: ComboRehab, Shenzhen Dongdixin Technology Co., Ltd. (2015) Summary page 6.

## Indications for use
This device is intended for use only in adult patients. Therapeutic Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1) Pain relief, muscle spasms and joint contractures. 2) Relief of pain, muscle spasms and joint contractures that may be associated with: - Adhesive capsulitis - Bursitis with slight calcification - Myositis - Soft tissue injuries - Shortened tendons due to past injuries and scar tissues 3) Relief of sub-chronic, chronic pain and joint contractures resulting from: - Capsular tightness - Capsular scarring For TENS, Interferential, premodulated (IFC), NMS and Microcurrent: 1) Symptomatic relief of chronic intractable pain 2) Post-traumatic acute pain 3) Post-surgical acute pain Additionally for NMS, NMS Burst, Hi-Volt and Russian: 1) Relaxation of Muscle spasms 2) Prevention or retardation of disuse atrophy 3) Increasing local blood circulation 4) Muscle re-education 5) Maintaining or increasing range of motion 6) Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis For DC Continuous Mode 1) Relaxation of muscle spasm

Source page: https://510kreport.com/device/K244041
Methodology: https://510kreport.com/methodology