510(k) · Cleared
ClearedEmg Retrainer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group, Inc. · HCC Device, Biofeedback
Cleared on Sep 26, 1997 as substantially equivalent to K897132 (The Prometheus Group, 1991) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1989. 10 later devices descend from it.
- Decided
- Sep 26, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K892649 (1989). 3 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK892649 Verimed Myoexorciser Iii (Myo Iii)Verimed Holdings, Inc. · 1989
- This deviceK972487 Emg RetrainerChattanooga Group, Inc. · 1997
- Descendant · cites it directly · 8 of its ownK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
- Descendant · 2 generations on · 1 of its ownK151640 Eltrac 471Enraf-Nonius, B.V. · 2015
- Descendant · 2 generations on · 0 of its ownK214037 Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK222912 c1TracZimmer Medizinsysteme GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK150695 ModpodHollywog, LLC · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006 · cites it directly8descendants
- K151640Eltrac 471Enraf-Nonius, B.V. · 2015 · 2 generations on1descendant
- K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024 · 2 generations on0descendants
- K222912c1TracZimmer Medizinsysteme GmbH · 2023 · 3 generations on0descendants
- K150695ModpodHollywog, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892649 | Verimed Myoexorciser Iii (Myo Iii) | Verimed Holdings, Inc. | 1989 | — |
| 0 (this device) | K972487 | Emg Retrainer | Chattanooga Group, Inc. | 1997 | — |
| +1 | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
| +2 | K151640 | Eltrac 471 | Enraf-Nonius, B.V. | 2015 | — |
| +2 | K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024 | — |
| +3 | K222912 | c1Trac | Zimmer Medizinsysteme GmbH | 2023 | — |
| +2 | K150695 | Modpod | Hollywog, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K897132 | Pathway II Electromyograph Our OCR of the scanned summary read K891732, FDA’s number for Thaisan Gloves (Patient Exam Gloves - Latex) (Thaisan Industries Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “The Prometheus Group Pathway II Electromyography”. | 1991 |
| * | K892649 | Verimed Myoexorciser Iii (Myo Iii)Summary page 4…rtable device for the measurement of muscle activity. It is similar to The Prometheus Group Pathway II Electromyography (510(k) K891732), Verimed Myoexerciser II (510(k) K892649), and Thought Technology Myotrac (510(k) K915858). [Reference Comparative Specifications on page 2-2]. System Description: The E… | 1989 |
| * | K915858 | MYOTRAC2Summary page 4…ity. It is similar to The Prometheus Group Pathway II Electromyography (510(k) K891732), Verimed Myoexerciser II (510(k) K892649), and Thought Technology Myotrac (510(k) K915858). [Reference Comparative Specifications on page 2-2]. System Description: The EMG Retrainer is a device used to measure the bioe… | 1992 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 ancestors has a recall.
- Of its descendants, K053223 (Chattanooga Group, 2006) has gone furthest, with 8 descendants of its own.
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?
1. To detemine the activation timing of muscles.
a) retraining of muscle activation
b) coordination of muscle activation
2. An indication of the force produced by muscle
a) control and maintenance of muscle contractions
3. For use in relaxation training and muscle re-education.
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/K972487 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972487: Emg Retrainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972487
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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