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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 116d · 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 59
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K082951.
PARKER 500
K110994 · Arjohuntleigh, Inc. · Jul 2011
MBATH 1000 (60)
K052479 · Enneking Medical, Inc. · Jan 2006
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
K040772 · Penner Manufacturing, Inc. · Apr 2004
CASCADE BATH, MODEL 6900
K012057 · Penner Manufacturing, Inc. · Jul 2001
SUPERIOR BATH, MODEL 6300
K012061 · Penner Manufacturing, Inc. · Jul 2001
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
K001079 · Arjo, Inc. · May 2000
K082951 · IMMERSION HYDROBATH
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