510(k) · Cleared
ClearedTNN-DU810 Non-Invasive Subdermal Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Tech Medical Systems, Ltd. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Apr 4, 2007 as substantially equivalent to K052340 (Alfa Tech Medical Systems, Ltd., 2005) and 1 other predicate after a 110-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Apr 4, 2007
- Review
- 110 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K984142 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 2 generations backK013192 Sonicator Plus 930, Model ME 930Mettler Electronics Corp. · 2001
- 1 generation backK052340 DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator SystemAlfa Tech Medical Systems, Ltd. · 2005
- This deviceK063728 TNN-DU810 Non-Invasive Subdermal Therapy SystemAlfa Tech Medical Systems, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −2 | K013192 | Sonicator Plus 930, Model ME 930 | Mettler Electronics Corp. | 2001 | — |
| −1 | K052340 | DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System | Alfa Tech Medical Systems, Ltd. | 2005 | — |
| 0 (this device) | K063728 | TNN-DU810 Non-Invasive Subdermal Therapy System | Alfa Tech Medical Systems, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K052340 | DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator SystemSummary page 4…Predicate device 2 Claimed device 510K# K052340 K024307 Device Name TNN-DU81O Non-Invasive Dermosonic Non-Invasive S… | 2005 |
| * | K024307 | Dermosonic Non-Invasive Subdermal Therapy SystemSummary page 2…l been cleared under the Mettler Electronics Corp. 510(k). Also included is a Dermosonic vacuum treatment roller head, cleared under the Dermosonic device, K024307. The TNN-DU810 device has dual frequencies ultrasound therapy, muscle stimulator systems and therapeutic vacuum massager. The us… | 2003 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K052340.
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. 2007, 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: 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase of blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques Neuromuscular Stimulation: 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles 4.…
Read the full statement (122 words)
Therapeutic Ultrasound:
1. Pain relief
2. Reduction of muscle spasm
3. Localized increase of blood flow
4. Increase range of motion of contracted joints using heat and stretch techniques
Neuromuscular Stimulation:
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increase of blood flow in the treatment area.
5. Prevention or retardation of disuse atrophy in post-injury type conditions
6. Muscle re-education
7. Maintaining or increasing range of motion
Therapeutic Massager:
1. Relieves muscle spasms
2. Provides temporary relief of minor muscle aches and pains
3. Temporarily improves local blood circulation
4. Temporarily reduces the appearance of cellulite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063728: TNN-DU810 Non-Invasive Subdermal Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063728
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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