Cleared Traditional

K082951 - IMMERSION HYDROBATH

K082951 is an FDA 510(k) clearance for IMMERSION HYDROBATH, manufactured by Arjo Hospital Equipment AB. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K082951 · Arjo Hospital Equipment AB · Physical Medicine device
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Apr 2009
Decision
187d
Days
Class 2
Risk

K082951 is an FDA 510(k) clearance for the IMMERSION HYDROBATH. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Arjo Hospital Equipment AB (Roselle, US). The FDA issued a Cleared decision on April 8, 2009 after a review of 187 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 Arjo Hospital Equipment AB devices

FDA 510(k) Submission Details - K082951

510(k) Number K082951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2008
Decision Date April 08, 2009
Days to Decision 187 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
72d slower than avg
Panel avg: 115d · This submission: 187d
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 8
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K082951.
VICHY SHOWER
K980909 · Bouvier Hydro, Inc. · Aug 1998
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