Cleared Traditional

K971592 - XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM

K971592 is an FDA 510(k) clearance for XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM, manufactured by The Silcraft Corp.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K971592 · The Silcraft Corp. · Physical Medicine device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K971592

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
Combination Product No
PCCP Authorized No
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.

ILJ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ILJ Bath, Hydro-massage

Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K971592.
HYDROTONE
K974321 · North American Technical Services Corp. · Jun 1998
FERNO HEALTHCARE RECLINE-A-BATH 2
K980033 · Ferno-Washington, Inc. · Apr 1998
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
K971593 · The Silcraft Corp. · Feb 1998
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
K964926 · Joerns Healthcare, Inc. · Nov 1997