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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 116d · 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 Consultant

Underwriters Laboratories, Inc.
CHANTEL CARSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K040772.
PARKER 500
K110994 · Arjohuntleigh, Inc. · Jul 2011
IMMERSION HYDROBATH
K082951 · Arjo Hospital Equipment AB · Apr 2009
MBATH 1000 (60)
K052479 · Enneking Medical, Inc. · Jan 2006
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

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K040772 · PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
Download PDF Penner Manufacturing,…