Cleared Traditional

K923396 - THERMODYN

K923396 is an FDA 510(k) clearance for THERMODYN, manufactured by Nemectron Medical, Inc.. The device is a Class 2 Physical Medicine device with product code IRT cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K923396 · Nemectron Medical, Inc. · Physical Medicine device
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May 1993
Decision
320d
Days
Class 2
Risk

K923396 is an FDA 510(k) clearance for the THERMODYN. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Nemectron Medical, Inc. (Temecula, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - 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. Elevated predicate reliance profile. 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 Nemectron Medical, Inc. devices

FDA 510(k) Submission Details - K923396

510(k) Number K923396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date May 26, 1993
Days to Decision 320 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 115d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRT Device Classification - Class 2, Special Controls

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
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 - IRT Pad, Heating, Powered

All 21
Devices cleared under the same product code (IRT) and FDA review panel - the closest regulatory comparables to K923396.
MOIST HEAT PAD
K924799 · Conair Corp. · Oct 1993
MOSIST HEAT PAD WITH AUTOMATIC OFF
K924800 · Conair Corp. · Oct 1993
KING SIZE HEAT PAD
K924885 · Conair Corp. · Oct 1993
SPORTS HEAT WRAP
K915241 · Conair Corp. · Dec 1991
INFRASSAGE MASSAGER
K902895 · Conair Corp. · Jul 1990
HYDRO-THERO PAD
K841697 · Maddak, Inc. · May 1984