Cleared Traditional

K050524 - EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000

K050524 is an FDA 510(k) clearance for EZ-IV MEDICAL PAD WARMING UNIT, manufactured by Marda Medical, Inc.. The device is a Class 1 Physical Medicine device with product code IRQ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K050524 · Marda Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
196d
Days
Class 1
Risk

K050524 is an FDA 510(k) clearance for the EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000. Classified as Unit, Heating, Powered (product code IRQ), Class I - General Controls.

Submitted by Marda Medical, Inc. (Jensen Beach, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 196 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5950 - 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.

FDA 510(k) Submission Details - K050524

510(k) Number K050524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date September 14, 2005
Days to Decision 196 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 116d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

IRQ Device Classification - Class 1, General Controls

Product Code IRQ Unit, Heating, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IRQ Unit, Heating, Powered

Devices cleared under the same product code (IRQ) and FDA review panel - the closest regulatory comparables to K050524.
THEMALATOR. MODELS T-4-S, T-8-S, ETC.
K950350 · Whitehall/Div Columbus Mckennon Corp. · Mar 1995
FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917
K924023 · Ferno · Apr 1993
ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)
K880644 · Fred Sammons, Inc. · May 1988
R1750 AND R1424 POWERED HEATING UNITS
K861340 · Tri W-G, Inc. · May 1986
PULSAIR MODEL SP-1
K832177 · Thermowave Medical Device Corp. · Dec 1983
K050524 · EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
Download PDF FDA Summary Marda Medical, Inc.