Cleared Traditional

K892649 - VERIMED MYOEXORCISER III (MYO III)

K892649 is an FDA 510(k) clearance for VERIMED MYOEXORCISER III (MYO III), manufactured by Verimed Holdings, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K892649 · Verimed Holdings, Inc. · Neurology device
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Dec 1989
Decision
245d
Days
Class 2
Risk

K892649 is an FDA 510(k) clearance for the VERIMED MYOEXORCISER III (MYO III). Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Verimed Holdings, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on December 13, 1989 after a review of 245 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K892649

510(k) Number K892649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1989
Decision Date December 13, 1989
Days to Decision 245 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 149d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HCC Device, Biofeedback

All 172
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K892649.
MYOTRACE 10 BIOFEEDBACK DEVICE
K895633 · Noraxon USA, Inc. · Apr 1990
BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH
K894510 · Capscan Corp. · Jan 1990
ELT OR ERGONOMIC LIFT TRAINER
K890500 · Physical Health Devices, Inc. · Jan 1990
ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM
K892114 · Eclosion, Inc. · Oct 1989
MYODAC2 BIOFEEDBACK DEVICE
K894840 · Thought Technology , Ltd. · Oct 1989
AUTOMATED THERAPY SYSTEM
K891693 · Harding & Harris, Inc. · Aug 1989
K892649 · VERIMED MYOEXORCISER III (MYO III)
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