Cleared Traditional

JETTA JR. HYDRO MASSAGE (K905599) - FDA 510(k) Clearance

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

K905599 · Jetta Products, Inc. · Physical Medicine device
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Mar 1991
Decision
103d
Days
Class 2
Risk

K905599 is an FDA 510(k) clearance for the JETTA JR. HYDRO MASSAGE. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Jetta Products, Inc. (Edmond, US). The FDA issued a Cleared decision on March 26, 1991 after a review of 103 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 Jetta Products, Inc. devices

Submission Details

510(k) Number K905599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1990
Decision Date March 26, 1991
Days to Decision 103 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 115d · This submission: 103d
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.