Cleared Traditional

A-2000 BATHING SYSTEMS (K992779) - FDA 510(k) Clearance

Also marketed or referenced as:
HYDROSONIC BATHIN SYSTEM

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

K992779 · Medi-Man Rehabilitation Products, Inc. · Physical Medicine device
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Jan 2000
Decision
148d
Days
Class 2
Risk

K992779 is an FDA 510(k) clearance for the A-2000 BATHING SYSTEMS. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Medi-Man Rehabilitation Products, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on January 13, 2000 after a review of 148 days - within the typical 510(k) review window.

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 Medi-Man Rehabilitation Products, Inc. devices

Submission Details

510(k) Number K992779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1999
Decision Date January 13, 2000
Days to Decision 148 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
33d slower than avg
Panel avg: 115d · This submission: 148d
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.