Cleared Traditional

K980909 - VICHY SHOWER

K980909 is an FDA 510(k) clearance for VICHY SHOWER, manufactured by Bouvier Hydro, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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

FDA 510(k) Submission Details - K980909

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
Combination Product No
PCCP Authorized No
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.

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 7
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K980909.
EQUINOXE
K980920 · Bouvier Hydro, Inc. · Jul 1998
HYDROTONE
K974321 · North American Technical Services Corp. · Jun 1998
FERNO HEALTHCARE RECLINE-A-BATH 2
K980033 · Ferno-Washington, Inc. · Apr 1998
WINDMERE MODEL DS-2 FOOT BATH
K980769 · Windmere Corp. · Mar 1998
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
K971592 · The Silcraft Corp. · Feb 1998
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
K971593 · The Silcraft Corp. · Feb 1998