ILJ · Class II · 21 CFR 890.5100

FDA Product Code ILJ: Bath, Hydro-massage

Leading manufacturers include Arjo-Century, Inc., Penner Manufacturing, Inc. and Bouvier Hydro, Inc..

73
Total
73
Cleared
125d
Avg days
1977
Since

FDA 510(k) Cleared Bath, Hydro-massage Devices (Product Code ILJ)

73 devices
1–24 of 73
Cleared Jul 06, 2011
PARKER 500
K110994
Arjohuntleigh, Inc.
Physical Medicine · 89d
Cleared Apr 08, 2009
IMMERSION HYDROBATH
K082951
Arjo Hospital Equipment AB
Physical Medicine · 187d
Cleared Jan 26, 2006
MBATH 1000 (60)
K052479
Enneking Medical, Inc.
Physical Medicine · 139d
Cleared Apr 05, 2004
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
K040772
Penner Manufacturing, Inc.
Physical Medicine · 10d
Cleared Jul 19, 2001
CASCADE BATH, MODEL 6900
K012057
Penner Manufacturing, Inc.
Physical Medicine · 17d
Cleared Jul 19, 2001
SUPERIOR BATH, MODEL 6300
K012061
Penner Manufacturing, Inc.
Physical Medicine · 17d
Cleared May 01, 2000
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
K001079
Arjo, Inc.
Physical Medicine · 27d
Cleared Feb 16, 2000
VANNA BATHING SYSTEM
K993872
Vancare, Inc.
Physical Medicine · 93d
Cleared Jan 13, 2000
A-2000 BATHING SYSTEMS
K992779
Medi-Man Rehabilitation Products, Inc.
Physical Medicine · 148d
Cleared Jun 23, 1999
HYDROTONE-THERMAL CAPSULE SYSTEM
K991184
Nats Corp.
Physical Medicine · 76d
Cleared Aug 11, 1998
VICHY SHOWER
K980909
Bouvier Hydro, Inc.
Physical Medicine · 154d
Cleared Jul 16, 1998
EQUINOXE
K980920
Bouvier Hydro, Inc.
Physical Medicine · 128d
Cleared Jun 22, 1998
HYDROTONE
K974321
North American Technical Services Corp.
Physical Medicine · 217d
Cleared Apr 21, 1998
FERNO HEALTHCARE RECLINE-A-BATH 2
K980033
Ferno-Washington, Inc.
Physical Medicine · 106d
Cleared Mar 27, 1998
WINDMERE MODEL DS-2 FOOT BATH
K980769
Windmere Corp.
Physical Medicine · 28d
Cleared Feb 26, 1998
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
K971592
The Silcraft Corp.
Physical Medicine · 301d
Cleared Feb 26, 1998
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
K971593
The Silcraft Corp.
Physical Medicine · 301d
Cleared Nov 03, 1997
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
K964926
Joerns Healthcare, Inc.
Physical Medicine · 329d
Cleared Nov 02, 1995
FREEDOM BATH
K952442
Grand Traverse Technologies
Physical Medicine · 161d
Cleared Aug 28, 1995
CENTURY BATHING SYSTEM
K930665
Arjo-Century, Inc.
Physical Medicine · 930d
Cleared Nov 09, 1994
AQUADYNE
K930820
Aquatherapy Systems, Inc.
Physical Medicine · 630d
Cleared Nov 09, 1994
THERA-FIT
K930821
Aquatherapy Systems, Inc.
Physical Medicine · 630d
Cleared Oct 17, 1994
MALIBU BATHING SYSTEM
K925195
Medi-Man Rehabilitation Products, Inc.
Physical Medicine · 732d
Cleared Aug 26, 1994
AQUACISER II
K925193
Aquaciser, Inc.
Physical Medicine · 680d

About Product Code ILJ - Regulatory Context