Cleared Traditional

BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC (K964926) - FDA 510(k) Clearance

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

K964926 · Joerns Healthcare, Inc. · Physical Medicine device
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Nov 1997
Decision
329d
Days
Class 2
Risk

K964926 is an FDA 510(k) clearance for the BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXE.... Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Joerns Healthcare, Inc. (Stevens Point, US). The FDA issued a Cleared decision on November 3, 1997 after a review of 329 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.

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Submission Details

510(k) Number K964926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date November 03, 1997
Days to Decision 329 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
214d slower than avg
Panel avg: 115d · This submission: 329d
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.