510(k) · Cleared
ClearedUltrasound Therapy Workstation (XMS-UET2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xemis Medical Technology (Shenzhen) Co., Ltd. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Oct 7, 2025 as substantially equivalent to K150436 (Shenzhen Dongdixin Technology Co., Ltd., 2015) after a 281-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Oct 7, 2025
- Review
- 281 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945509 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK945509 FX-2 NMS (2CHANNEL Table Model)Fx-2 · 1995
- 2 generations backK062354 Vectra Genisys VMS FREncore Medical L.P. · 2007
- 1 generation backK150436 ComboRehabShenzhen Dongdixin Technology Co., Ltd. · 2015
- This deviceK244041 Ultrasound Therapy Workstation (XMS-UET2)Xemis Medical Technology (Shenzhen) Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945509 | FX-2 NMS (2CHANNEL Table Model) | Fx-2 | 1995 | — |
| −2 | K062354 | Vectra Genisys VMS FR | Encore Medical L.P. | 2007 | — |
| −1 | K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | 2015 | — |
| 0 (this device) | K244041 | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150436 | ComboRehabSummary page 6…tional 510(K) 4. Predicate Device Device name and model K number Manufacturer Predicate ComboRehab K150436 Shenzhen Dongdixin device Technology Co. Ltd. 5. Device… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 9.9 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All IMG devicesIMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · IMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMG
226in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMG
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMG
9in 2025
MAUDE reports naming product code IMG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 110 | 0 | 0 |
| 2008 | 0 | — | 2 | 37 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 3 | 226 | 0 | 21 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (170 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K244041 · printed Nov 5, 2026
Cite this page
510(k) Report. “K244041: Ultrasound Therapy Workstation (XMS-UET2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K244041
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026