Cleared Traditional

K841579 - MULTIPLEX I, INTERFERENTIAL CURRENT

K841579 is an FDA 510(k) clearance for MULTIPLEX I, manufactured by Houwers Enterprises , Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K841579 · Houwers Enterprises , Ltd. · Physical Medicine device
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May 1984
Decision
23d
Days
Class 2
Risk

K841579 is an FDA 510(k) clearance for the MULTIPLEX I, INTERFERENTIAL CURRENT. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Houwers Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 10, 1984 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Houwers Enterprises , Ltd. devices

FDA 510(k) Submission Details - K841579

510(k) Number K841579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date May 10, 1984
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 274
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K841579.
INTERFERENZ 4
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NEUROMEDICS ULTRASTIM 650-01
K841647 · Intermedics, Inc. · Jul 1984
EMPI MODEL 712, LOGIX, NMS
K841382 · Empi · May 1984
ELECTRICAL NEURO-MUSCULAR STIMULATOR
K840895 · Richards Medical Co., Inc. · Apr 1984
NEUROMUSCULAR STIMULATOR 3105
K840467 · Medtronic Vascular · Feb 1984