Cleared Traditional

K991427 - PARAMED PARAFFIN WARMER

K991427 is an FDA 510(k) clearance for PARAMED PARAFFIN WARMER, manufactured by Divi Intl. Co.. The device is a Class 2 Physical Medicine device with product code IMC cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K991427 · Divi Intl. Co. · Physical Medicine device
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Aug 1999
Decision
112d
Days
Class 2
Risk

K991427 is an FDA 510(k) clearance for the PARAMED PARAFFIN WARMER. Classified as Bath, Paraffin (product code IMC), Class II - Special Controls.

Submitted by Divi Intl. Co. (Miami, US). The FDA issued a Cleared decision on August 13, 1999 after a review of 112 days - within the typical 510(k) review window.

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: 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 Divi Intl. Co. devices

FDA 510(k) Submission Details - K991427

510(k) Number K991427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1999
Decision Date August 13, 1999
Days to Decision 112 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 115d · This submission: 112d
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.