Cleared Traditional

K844389 - ESCOTEK EST 210

K844389 is the FDA 510(k) clearance for ESCOTEK EST 210 by Nor-Am Patient Care Products, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K844389 · Nor-Am Patient Care Products, Inc. · Physical Medicine device
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May 1985
Decision
175d
Days
Class 2
Risk

K844389 is an FDA 510(k) clearance for the ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Nor-Am Patient Care Products, Inc. (Walker, US). The FDA issued a Cleared decision on May 7, 1985 after a review of 175 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 Nor-Am Patient Care Products, Inc. devices

Submission Details

510(k) Number K844389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date May 07, 1985
Days to Decision 175 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
60d slower than avg
Panel avg: 115d · This submission: 175d
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 153
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K844389.
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THE PROBE 100
K844466 · Rich-Mar Corp. · Feb 1985