Cleared Traditional

K861346 - R1363 PARAFFIN

K861346 is an FDA 510(k) clearance for R1363 PARAFFIN, manufactured by Tri W-G, Inc.. The device is a Class 2 Physical Medicine device with product code IMC cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K861346 · Tri W-G, Inc. · Physical Medicine device
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May 1986
Decision
25d
Days
Class 2
Risk

K861346 is an FDA 510(k) clearance for the R1363 PARAFFIN. Classified as Bath, Paraffin (product code IMC), Class II - Special 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 890.5110 - 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 - K861346

510(k) Number K861346 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. No clinical trials required.

IMC Device Classification - Class 2, Special Controls

Product Code IMC Bath, Paraffin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5110
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 - IMC Bath, Paraffin

All 11
Devices cleared under the same product code (IMC) and FDA review panel - the closest regulatory comparables to K861346.
PARAMED PARAFFIN WARMER
K991427 · Divi Intl. Co. · Aug 1999
PARA-CARE
K980718 · Chattanooga Group, Inc. · Mar 1998
R1124 & R1686 PARAFFIN
K861344 · Tri W-G, Inc. · May 1986
PARA THERM BATH
K842423 · Grimm Scientific Industries, Inc. · Jun 1984
THERMAMED BATH
K833631 · Bernlit Enterprises, Inc. · Nov 1983
MADDATHERM PARAFFIN BATH
K770170 · Techhnilab Instruments, Inc. · Jan 1977
K861346 · R1363 PARAFFIN
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