Cleared Traditional

K844386 - ESCOTEK-EST 301A ULTRA-SONIC UNIT

K844386 is an FDA 510(k) clearance for ESCOTEK-EST 301A ULTRA-SONIC UNIT, manufactured by Nor-Am Patient Care Products, Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K844386 · Nor-Am Patient Care Products, Inc. · Physical Medicine device
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May 1985
Decision
169d
Days
Class 2
Risk

K844386 is an FDA 510(k) clearance for the ESCOTEK-EST 301A ULTRA-SONIC UNIT. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Nor-Am Patient Care Products, Inc. (Walker, US). The FDA issued a Cleared decision on May 1, 1985 after a review of 169 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - 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

FDA 510(k) Submission Details - K844386

510(k) Number K844386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date May 01, 1985
Days to Decision 169 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
54d slower than avg
Panel avg: 115d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
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 - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 64
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K844386.
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K872393 · Henley Intl. · Jul 1987
SONOMED 4
K851937 · Robert Bosch Corp. · Jul 1985
SONICATOR 705 MODEL ME 705
K851397 · Mettler Electronics Corp. · Jul 1985
US 610
K844036 · Rich-Mar Corp. · Nov 1984
MEGASON MODEL 150
K843221 · Birtcher Corp. · Aug 1984
INTELECT 205 PORTABLE ULTRASOUND UNIT
K841445 · Chattanooga Group, Inc. · May 1984