Cleared Traditional

K874212 - VERIMED MYO/PREMS

K874212 is the FDA 510(k) clearance for VERIMED MYO/PREMS by Verimed Holdings, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K874212 · Verimed Holdings, Inc. · Physical Medicine device
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Aug 1988
Decision
297d
Days
Class 2
Risk

K874212 is an FDA 510(k) clearance for the VERIMED MYO/PREMS. 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 August 8, 1988 after a review of 297 days - an extended review cycle.

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. Standard predicate reliance. 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 K874212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1987
Decision Date August 08, 1988
Days to Decision 297 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
182d slower than avg
Panel avg: 115d · This submission: 297d
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 K874212.
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
K893994 · Rich-Mar Corp. · Dec 1989
ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
K884651 · Biomedical Life Systems, Inc. · Nov 1989
RICH-MAR CONDUCTIVE GEL II W/ALOE VERA
K890147 · Rich-Mar Corp. · Mar 1989
ENDOMED CV405
K880699 · Henley Intl. · May 1988
RICH-MAR G1000 EMS
K880948 · Rich-Mar Corp. · Apr 1988
INTELECT MODEL 120
K880235 · Chattanooga Group, Inc. · Apr 1988