Cleared Traditional

K911758 - AMISH COUNTRY SPA

K911758 is an FDA 510(k) clearance for AMISH COUNTRY SPA, manufactured by Fox Pool Corp.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K911758 · Fox Pool Corp. · Physical Medicine device
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Oct 1991
Decision
167d
Days
Class 2
Risk

K911758 is an FDA 510(k) clearance for the AMISH COUNTRY SPA. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Fox Pool Corp. (York, US). The FDA issued a Cleared decision on October 2, 1991 after a review of 167 days - an extended review cycle.

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. 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 Fox Pool Corp. devices

FDA 510(k) Submission Details - K911758

510(k) Number K911758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1991
Decision Date October 02, 1991
Days to Decision 167 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 115d · This submission: 167d
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

All 14
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K911758.
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
K971592 · The Silcraft Corp. · Feb 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