Cleared Traditional

K040772 - PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM

K040772 is an FDA 510(k) clearance for PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BAT..., manufactured by Penner Manufacturing, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K040772 · Penner Manufacturing, Inc. · Physical Medicine device
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Apr 2004
Decision
10d
Days
Class 2
Risk

K040772 is an FDA 510(k) clearance for the PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Penner Manufacturing, Inc. (Ohaha, US). The FDA issued a Cleared decision on April 5, 2004 after a review of 10 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Penner Manufacturing, Inc. devices

FDA 510(k) Submission Details - K040772

510(k) Number K040772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2004
Decision Date April 05, 2004
Days to Decision 10 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 12
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K040772.
PARKER 500
K110994 · Arjohuntleigh, Inc. · Jul 2011
VANNA BATHING SYSTEM
K993872 · Vancare, Inc. · Feb 2000
A-2000 BATHING SYSTEMS
K992779 · Medi-Man Rehabilitation Products, Inc. · Jan 2000
HYDROTONE-THERMAL CAPSULE SYSTEM
K991184 · Nats Corp. · Jun 1999
VICHY SHOWER
K980909 · Bouvier Hydro, Inc. · Aug 1998
EQUINOXE
K980920 · Bouvier Hydro, Inc. · Jul 1998