Cleared Traditional

XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM (K971592) - FDA 510(k) Clearance

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

K971592 · The Silcraft Corp. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Feb 1998
Decision
301d
Days
Class 2
Risk

K971592 is an FDA 510(k) clearance for the XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by The Silcraft Corp. (Washington, US). The FDA issued a Cleared decision on February 26, 1998 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5100 - 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. Elevated predicate reliance profile. 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 The Silcraft Corp. devices

Submission Details

510(k) Number K971592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date February 26, 1998
Days to Decision 301 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
186d slower than avg
Panel avg: 115d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILJ Bath, Hydro-massage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5100
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.