Cleared Abbreviated

K110994 - PARKER 500

K110994 is an FDA 510(k) clearance for PARKER 500, manufactured by Arjohuntleigh, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Abbreviated 510(k) pathway after a 89-day FDA review.

K110994 · Arjohuntleigh, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
89d
Days
Class 2
Risk

K110994 is an FDA 510(k) clearance for the PARKER 500. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Arjohuntleigh, Inc. (Addison, US). The FDA issued a Cleared decision on July 6, 2011 after a review of 89 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K110994

510(k) Number K110994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2011
Decision Date July 06, 2011
Days to Decision 89 days
Submission Type Abbreviated
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
27d faster than avg
Panel avg: 116d · This submission: 89d
Pathway characteristics
Standards-based clearance path.

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 35
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K110994.
IMMERSION HYDROBATH
K082951 · Arjo Hospital Equipment AB · Apr 2009
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
K110994 · PARKER 500
Download PDF FDA Summary Arjohuntleigh, Inc.