Cleared Traditional

K902603 - LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH

K902603 is an FDA 510(k) clearance for LIBERTY, manufactured by Unique Bathing Supplies, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K902603 · Unique Bathing Supplies, Inc. · Physical Medicine device
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Jun 1990
Decision
17d
Days
Class 2
Risk

K902603 is an FDA 510(k) clearance for the LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Unique Bathing Supplies, Inc. (Troy, US). The FDA issued a Cleared decision on June 29, 1990 after a review of 17 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Unique Bathing Supplies, Inc. devices

FDA 510(k) Submission Details - K902603

510(k) Number K902603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1990
Decision Date June 29, 1990
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 K902603.
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