Cleared Traditional

K893220 - VERIMED MYOEXORCISER VERISTIM

K893220 is the FDA 510(k) clearance for VERIMED MYOEXORCISER VERISTIM by Verimed Holdings, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K893220 · Verimed Holdings, Inc. · Physical Medicine device
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Mar 1990
Decision
314d
Days
Class 2
Risk

K893220 is an FDA 510(k) clearance for the VERIMED MYOEXORCISER VERISTIM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Verimed Holdings, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on March 7, 1990 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Verimed Holdings, Inc. devices

Submission Details

510(k) Number K893220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1989
Decision Date March 07, 1990
Days to Decision 314 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 115d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 150
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K893220.
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K895301 · Henley Intl. · Feb 1990
MULTISTIM PLUS
K895983 · Excel Tech. , Ltd. · Feb 1990