Cleared Traditional

K893220 - VERIMED MYOEXORCISER VERISTIM

K893220 is an FDA 510(k) clearance for VERIMED MYOEXORCISER VERISTIM, manufactured by Verimed Holdings, Inc.. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K893220

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.

IPF Device Classification - Class 2, Special Controls

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 266
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K893220.
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EMS 8100
K895301 · Henley Intl. · Feb 1990
MULTISTIM PLUS
K895983 · Excel Tech. , Ltd. · Feb 1990