Cleared Traditional

K014019 - NEUROTECH MEDISTIM PLUS

K014019 is the FDA 510(k) clearance for NEUROTECH MEDISTIM PLUS by Bio-Medical Research, Ltd.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K014019 · Bio-Medical Research, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
217d
Days
Class 2
Risk

K014019 is an FDA 510(k) clearance for the NEUROTECH MEDISTIM PLUS, TYPE 291. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on July 11, 2002 after a review of 217 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 Bio-Medical Research, Ltd. devices

Submission Details

510(k) Number K014019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2001
Decision Date July 11, 2002
Days to Decision 217 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 115d · This submission: 217d
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 135
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K014019.
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MODIFICATION TO: WINNER ST-2 STIMULATOR
K013770 · Rich-Mar Corp. · Jan 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K013771 · Rich-Mar Corp. · Jan 2002