Cleared Traditional

VICHY SHOWER (K980909) - FDA 510(k) Clearance

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

K980909 · Bouvier Hydro, Inc. · Physical Medicine device
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Aug 1998
Decision
154d
Days
Class 2
Risk

K980909 is an FDA 510(k) clearance for the VICHY SHOWER. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Bouvier Hydro, Inc. (Champlain,, US). The FDA issued a Cleared decision on August 11, 1998 after a review of 154 days - an extended review 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: 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 Bouvier Hydro, Inc. devices

Submission Details

510(k) Number K980909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1998
Decision Date August 11, 1998
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
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.