Cleared Traditional

K874232 - MUSCLE STIM. DEVICES

K874232 is the FDA 510(k) clearance for MUSCLE STIM. DEVICES by Health Systems Intl., Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 512-day FDA review.

K874232 · Health Systems Intl., Inc. · Physical Medicine device
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Mar 1989
Decision
512d
Days
Class 2
Risk

K874232 is an FDA 510(k) clearance for the MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Health Systems Intl., Inc. (Alexandria, US). The FDA issued a Cleared decision on March 10, 1989 after a review of 512 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Health Systems Intl., Inc. devices

Submission Details

510(k) Number K874232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1987
Decision Date March 10, 1989
Days to Decision 512 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
397d slower than avg
Panel avg: 115d · This submission: 512d
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 141
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K874232.
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