510(k) · Cleared
ClearedSurface Electromyograph Biofeedback Muscle Activity Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J-Tech, Inc. · HCC Device, Biofeedback
Cleared on Jul 3, 1996 as substantially equivalent to K912938 (Stellate Systems, 1991) and 1 other predicate after a 261-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jul 3, 1996
- Review
- 261 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912938 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912938 RhythmStellate Systems · 1991
- This deviceK954737 Surface Electromyograph Biofeedback Muscle Activity DeviceJ-Tech, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912938 | Rhythm | Stellate Systems | 1991 | — |
| 0 (this device) | K954737 | Surface Electromyograph Biofeedback Muscle Activity Device | J-Tech, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 HCC? 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 HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K912938 | RhythmSummary page 1…12.1 ldentification of Legally Marketed Device The JTech Dynatrack SEMG System is substantially equivalent to the class Il Targus Concepts Biostar SEMG System Device (K912938), the Tracker Microprocessor, and the Tracker PC Software of the Large Muscle Strength Gauge (K944630). 12.2 JTech Dynatrack SE… | 1991 |
| * | K945630 | Large Muscle Strength Gauge Our OCR of the scanned summary read K944630, FDA’s number for Model 230-Sas Laser Delivery Probe (Mnlase, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Tracker Microprocessor and Tracker PC Software of the Large Muscle…”. | 1995 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K912938.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The JTech Dynatrack Surface Electromyograph is a biofeedback device that provides a visual signal corresponding to the status of a patient’s muscle activity. Healthcare professionals can use the machine to monitor the patient’s muscle activity. This is a precise biofeedback instrument for quick and accurate assessment and recording of the bioelectric muscie signal. It is compliant with the National Bureau of Standards calibration standards for microvolts.
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/K954737 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954737: Surface Electromyograph Biofeedback Muscle Activity Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954737
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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