Cleared Traditional

K980718 - PARA-CARE

K980718 is an FDA 510(k) clearance for PARA-CARE, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Physical Medicine device with product code IMC cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K980718 · Chattanooga Group, Inc. · Physical Medicine device
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Mar 1998
Decision
31d
Days
Class 2
Risk

K980718 is an FDA 510(k) clearance for the PARA-CARE. Classified as Bath, Paraffin (product code IMC), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on March 27, 1998 after a review of 31 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.

View all Chattanooga Group, Inc. devices

FDA 510(k) Submission Details - K980718

510(k) Number K980718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1998
Decision Date March 27, 1998
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
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.