Cleared Traditional

K052479 - MBATH 1000 (60)

K052479 is an FDA 510(k) clearance for MBATH 1000 (60), manufactured by Enneking Medical, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K052479 · Enneking Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
139d
Days
Class 2
Risk

K052479 is an FDA 510(k) clearance for the MBATH 1000 (60). Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Enneking Medical, Inc. (Kansas City, US). The FDA issued a Cleared decision on January 26, 2006 after a review of 139 days - within the typical 510(k) review window.

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 - K052479

510(k) Number K052479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2005
Decision Date January 26, 2006
Days to Decision 139 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 116d · This submission: 139d
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 K052479.
PARKER 500
K110994 · Arjohuntleigh, Inc. · Jul 2011
IMMERSION HYDROBATH
K082951 · Arjo Hospital Equipment AB · Apr 2009
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
K052479 · MBATH 1000 (60)
Download PDF FDA Summary Enneking Medical, Inc.