510(k) · Cleared
ClearedMega ME 3000 Professional Muscle Tester
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mega Electronics, Ltd. · HCC Device, Biofeedback
Cleared on May 19, 1997 as substantially equivalent to K881416 (Thought Technology, Ltd., 1988) and 2 other predicates after a 277-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- May 19, 1997
- Review
- 277 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K832714 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832714 Verimed MyoexorciserVerimed Holdings, Inc. · 1983
- This deviceK963202 Mega ME 3000 Professional Muscle TesterMega Electronics, Ltd. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832714 | Verimed Myoexorciser | Verimed Holdings, Inc. | 1983 | — |
| 0 (this device) | K963202 | Mega ME 3000 Professional Muscle Tester | Mega Electronics, Ltd. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 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 |
|---|---|---|---|
| * | K881416 | MyotracSummary page 1…50 70211 Kuopio Finland tel: 358 71 282 8959 Submitted by Regulatory Strategies, Inc. Consultant to Mega Electronics, Ltd. Predi vi Myotrac from Thought Technology K881416 Myoexcerciser from Verimed K832714 Myosystem 1000/2000 from Noraxon K895635 Device Description The ME3000P is a portable, batte… | 1988 |
| * | K832714 | Verimed MyoexorciserSummary page 1…71 282 8959 Submitted by Regulatory Strategies, Inc. Consultant to Mega Electronics, Ltd. Predi vi Myotrac from Thought Technology K881416 Myoexcerciser from Verimed K832714 Myosystem 1000/2000 from Noraxon K895635 Device Description The ME3000P is a portable, battery powered EMG recorder. Te ologi… | 1983 |
| * | K895635 | Myosystem 1000 ElectromyographSummary page 1…tegies, Inc. Consultant to Mega Electronics, Ltd. Predi vi Myotrac from Thought Technology K881416 Myoexcerciser from Verimed K832714 Myosystem 1000/2000 from Noraxon K895635 Device Description The ME3000P is a portable, battery powered EMG recorder. Te ologi Ch teristics The ME3000P is an electroni… | 1990 |
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 3 ancestors has a recall.
- 2 other devices also cite its predicate K881416.
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 intended use of the Model ME30OOP Professional Muscle Tester is
to record EMG sensory feedback signals to be used in various programs
of muscle re-education and relaxation training
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/K963202 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963202: Mega ME 3000 Professional Muscle Tester.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963202
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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