Cleared Traditional

K930820 - AQUADYNE

K930820 is an FDA 510(k) clearance for AQUADYNE, manufactured by Aquatherapy Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 630-day FDA review.

K930820 · Aquatherapy Systems, Inc. · Physical Medicine device
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Nov 1994
Decision
630d
Days
Class 2
Risk

K930820 is an FDA 510(k) clearance for the AQUADYNE. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Aquatherapy Systems, Inc. (Lafayette Hill, US). The FDA issued a Cleared decision on November 9, 1994 after a review of 630 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Aquatherapy Systems, Inc. devices

FDA 510(k) Submission Details - K930820

510(k) Number K930820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1993
Decision Date November 09, 1994
Days to Decision 630 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
515d slower than avg
Panel avg: 115d · This submission: 630d
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 13
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K930820.
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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