510(k) · Cleared
ClearedComboRehab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dongdixin Technology Co., Ltd. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Nov 13, 2015 as substantially equivalent to K062354 (Encore Medical L.P., 2007) and 1 other predicate after a 267-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Nov 13, 2015
- Review
- 267 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945509 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK945509 FX-2 NMS (2CHANNEL Table Model)Fx-2 · 1995
- 1 generation backK062354 Vectra Genisys VMS FREncore Medical L.P. · 2007
- This deviceK150436 ComboRehabShenzhen Dongdixin Technology Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK244041 Ultrasound Therapy Workstation (XMS-UET2)Xemis Medical Technology (Shenzhen) Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K244041Ultrasound Therapy Workstation (XMS-UET2)Xemis Medical Technology (Shenzhen) Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945509 | FX-2 NMS (2CHANNEL Table Model) | Fx-2 | 1995 | — |
| −1 | K062354 | Vectra Genisys VMS FR | Encore Medical L.P. | 2007 | — |
| 0 (this device) | K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
Top candidate predicates for a new IMG device
- #1 K244041 Ultrasound Therapy Workstation (XMS-UET2)score 10.7 · 3 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K062354 | Vectra Genisys VMS FRSummary page 6…al neuromuscular stimulator 1.3. Classification: Class II 1.4. Product Code: IMG, GZJ, GZI, IPF, LIH, HCC 2. Predicate Device: 2.1. Chattanooga Vectra Genisys -- K062354 2.2. CT1000 SonicStimu Combo -- K120217 3. Description of Proposed Device: ComboRehab is four channels combination unit, c… | 2007 |
| * | K120217 | Sonicstimu Combo Therapeutic DeviceSummary page 6…ication: Class II 1.4. Product Code: IMG, GZJ, GZI, IPF, LIH, HCC 2. Predicate Device: 2.1. Chattanooga Vectra Genisys -- K062354 2.2. CT1000 SonicStimu Combo -- K120217 3. Description of Proposed Device: ComboRehab is four channels combination unit, can provide muscle stimulation, ultrasound,… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) | 2025 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K244041 (Xemis Medical Technology (Shenzhen) Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K062354.
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. 2015, 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?
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…
Read the full statement (237 words)
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 EMG
To determine the activation timing of muscles for:
1. Retaining of muscle activation
2. Coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
1. Relaxation muscle training
2. Muscle re-education
For EMG triggered Stim
1. Stroke rehab by muscle re-education
2. Relaxation of muscle spasms
3. Prevention or retardation of disuse atrophy
4. Increase local blood circulation
5. Muscle re-education
6. Maintaining or increasing range of motion
For DC Continuous Mode
Relaxation of muscle spasm
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150436: ComboRehab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150436
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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