FDA 510(k) Applications for Medical Device Product Code "ILJ"
(Bath, Hydro-Massage)

FDA 510(k) Number Applicant Device Name Decision Date
K082951 ARJO HOSPITAL EQUIPMENT AB IMMERSION HYDROBATH 04/08/2009
K001079 ARJO, INC. RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO 05/01/2000
K110994 ARJOHUNTLEIGH INC PARKER 500 07/06/2011
K980920 BOUVIER HYDRO, INC. EQUINOXE 07/16/1998
K980909 BOUVIER HYDRO, INC. VICHY SHOWER 08/11/1998
K052479 ENNEKING MEDICAL INC. MBATH 1000 (60) 01/26/2006
K980033 FERNO-WASHINGTON, INC. FERNO HEALTHCARE RECLINE-A-BATH 2 04/21/1998
K964926 JOERNS HEALTHCARE, INC. BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC 11/03/1997
K992779 MEDI-MAN REHABILITATION PRODUCTS, INC. A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM 01/13/2000
K991184 NATS CORP. HYDROTONE-THERMAL CAPSULE SYSTEM 06/23/1999
K974321 NORTH AMERICAN TECHNICAL SERVICES CORP. HYDROTONE 06/22/1998
K012057 PENNER MANUFACTURING, INC. CASCADE BATH, MODEL 6900 07/19/2001
K040772 PENNER MANUFACTURING, INC. PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM 04/05/2004
K012061 PENNER MANUFACTURING, INC. SUPERIOR BATH, MODEL 6300 07/19/2001
K971593 THE SILCRAFT CORP. SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT 02/26/1998
K971592 THE SILCRAFT CORP. XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM 02/26/1998
K993872 VANCARE, INC. VANNA BATHING SYSTEM 02/16/2000
K980769 WINDMERE CORP. WINDMERE MODEL DS-2 FOOT BATH 03/27/1998


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