510(k) Report

510(k) · Cleared

Cleared

Verimed Myoexorciser

K832714510(k) TraditionalCleared Oct 28, 198377-day reviewClass II21 CFR 882.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Verimed Holdings, Inc. · HCC Device, Biofeedback

Cleared on Oct 28, 1983 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Oct 28, 1983
Review
77 days
Class
Class II
Product code
HCC
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared19801990200020102020
  1. This deviceK832714 Verimed MyoexorciserVerimed Holdings, Inc. · 1983
  2. Descendant · cites it directly · 0 of its ownK943535 Model ME 300 Muscle TesterRegulatory Strategies, Inc. · 1997
  3. Descendant · cites it directly · 0 of its ownK963202 Mega ME 3000 Professional Muscle TesterMega Electronics, Ltd. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K943535Model ME 300 Muscle TesterRegulatory Strategies, Inc. · 1997 · cites it directly0descendants
  • K963202Mega ME 3000 Professional Muscle TesterMega Electronics, Ltd. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K832714Verimed MyoexorciserVerimed Holdings, Inc.1983—
+1K943535Model ME 300 Muscle TesterRegulatory Strategies, Inc.1997—
+1K963202Mega ME 3000 Professional Muscle TesterMega Electronics, Ltd.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
FIG. 1 — Lineage of K832714, 1983–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K943535Model ME 300 Muscle TesterRegulatory Strategies, Inc.19970
K963202Mega ME 3000 Professional Muscle TesterMega Electronics, Ltd.19970

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?

  • Of its descendants, K943535 (Regulatory Strategies, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HCC devices

HCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCC

1in 2024

2007: 12008: 22010: 12011: 12013: 22015: 22017: 12018: 12023: 12024: 1
2007high 2 (2008) · low 0 (2009)2026

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

2012: 12015: 1
2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HCC

5in 2024

2007: 22008: 22009: 12011: 42012: 22013: 22014: 22016: 42017: 32018: 12019: 62020: 22022: 32023: 22024: 5
2007high 6 (2019) · low 0 (2010)2025

MAUDE reports naming product code HCC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20082—02
20090—01
20101—00
20111—04
20120—12
20132—02
20140—02
20152—10
20160—04
20171—03
20181—01
20190—06
20200—02
20210—00
20220—03
20231—02
20241—05
20250—00
20260—0—
Cite this page

510(k) Report. “K832714: Verimed Myoexorciser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832714

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026