ILJ · Bath, Hydro-Massage
Physical Medicine · 21 CFR 890.5100 · Class 2
Overview
| Product Code | ILJ |
|---|---|
| Device Name | Bath, Hydro-Massage |
| Regulation | 21 CFR 890.5100 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.
Classification Rationale
Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Recent Cleared Devices (20 of 73)
Showing 20 most recent of 73 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110994 | PARKER 500 | Arjohuntleigh, Inc. | Jul 6, 2011 | SESE |
| K082951 | IMMERSION HYDROBATH | Arjo Hospital Equipment AB | Apr 8, 2009 | SESE |
| K052479 | MBATH 1000 (60) | Enneking Medical, Inc. | Jan 26, 2006 | SESE |
| K040772 | PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM | Penner Manufacturing, Inc. | Apr 5, 2004 | SESE |
| K012061 | SUPERIOR BATH, MODEL 6300 | Penner Manufacturing, Inc. | Jul 19, 2001 | SESE |
| K012057 | CASCADE BATH, MODEL 6900 | Penner Manufacturing, Inc. | Jul 19, 2001 | SESE |
| K001079 | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO | Arjo, Inc. | May 1, 2000 | SESE |
| K993872 | VANNA BATHING SYSTEM | Vancare, Inc. | Feb 16, 2000 | SESE |
| K992779 | A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM | Medi-Man Rehabilitation Products, Inc. | Jan 13, 2000 | SESE |
| K991184 | HYDROTONE-THERMAL CAPSULE SYSTEM | Nats Corp. | Jun 23, 1999 | SESE |
| K980909 | VICHY SHOWER | Bouvier Hydro, Inc. | Aug 11, 1998 | SESE |
| K980920 | EQUINOXE | Bouvier Hydro, Inc. | Jul 16, 1998 | SESE |
| K974321 | HYDROTONE | North American Technical Services Corp. | Jun 22, 1998 | SESE |
| K980033 | FERNO HEALTHCARE RECLINE-A-BATH 2 | Ferno-Washington, Inc. | Apr 21, 1998 | SESE |
| K980769 | WINDMERE MODEL DS-2 FOOT BATH | Windmere Corp. | Mar 27, 1998 | SESE |
| K971593 | SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT | The Silcraft Corp. | Feb 26, 1998 | SESE |
| K971592 | XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM | The Silcraft Corp. | Feb 26, 1998 | SESE |
| K964926 | BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC | Joerns Healthcare, Inc. | Nov 3, 1997 | SESE |
| K952442 | FREEDOM BATH | Grand Traverse Technologies | Nov 2, 1995 | SESE |
| K930665 | CENTURY BATHING SYSTEM | Arjo-Century, Inc. | Aug 28, 1995 | SESE |
Top Applicants
- Dazey Products Co. — 6 clearances
- Arjo-Century, Inc. — 4 clearances
- Setma, Inc. — 4 clearances
- Century Manufacturing Co. — 3 clearances
- Heddernheimer Metallwarenfabrik GmbH — 3 clearances
