Cleared Traditional

K861340 - R1750 AND R1424 POWERED HEATING UNITS

K861340 is an FDA 510(k) clearance for R1750 AND R1424 POWERED HEATING UNITS, manufactured by Tri W-G, Inc.. The device is a Class 1 Physical Medicine device with product code IRQ cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K861340 · Tri W-G, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
25d
Days
Class 1
Risk

K861340 is an FDA 510(k) clearance for the R1750 AND R1424 POWERED HEATING UNITS. Classified as Unit, Heating, Powered (product code IRQ), Class I - General Controls.

Submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 25 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K861340

510(k) Number K861340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1986
Decision Date May 02, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 116d · This submission: 25d
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 K861340.
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
PULSAIR MODEL SP-1
K832177 · Thermowave Medical Device Corp. · Dec 1983
THERMOLATOR HEATING UNIT
K801625 · Tru-Eze Mfg. Co., Inc. · Jul 1980
K861340 · R1750 AND R1424 POWERED HEATING UNITS
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