Cleared Traditional

SOFTIQUE, MODEL GI 11001 (K013707) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013707 · Global TV Concepts, Ltd. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Feb 2002
Decision
85d
Days
Class 2
Risk

K013707 is an FDA 510(k) clearance for the SOFTIQUE, MODEL GI 11001. Classified as Bath, Paraffin (product code IMC), Class II - Special Controls.

Submitted by Global TV Concepts, Ltd. (Deerfield Beach, US). The FDA issued a Cleared decision on February 1, 2002 after a review of 85 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 Global TV Concepts, Ltd. devices

Submission Details

510(k) Number K013707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2001
Decision Date February 01, 2002
Days to Decision 85 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.