Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5100](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5100) → ILJ — Bath, Hydro-Massage # ILJ · Bath, Hydro-Massage _Physical Medicine · 21 CFR 890.5100 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ ## Overview - **Product Code:** ILJ - **Device Name:** Bath, Hydro-Massage - **Regulation:** [21 CFR 890.5100](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5100) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K110994.md) | PARKER 500 | Arjohuntleigh, Inc. | Jul 6, 2011 | SESE | | [K082951](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K082951.md) | IMMERSION HYDROBATH | Arjo Hospital Equipment AB | Apr 8, 2009 | SESE | | [K052479](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K052479.md) | MBATH 1000 (60) | Enneking Medical, Inc. | Jan 26, 2006 | SESE | | [K040772](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K040772.md) | PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM | Penner Manufacturing, Inc. | Apr 5, 2004 | SESE | | [K012061](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K012061.md) | SUPERIOR BATH, MODEL 6300 | Penner Manufacturing, Inc. | Jul 19, 2001 | SESE | | [K012057](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K012057.md) | CASCADE BATH, MODEL 6900 | Penner Manufacturing, Inc. | Jul 19, 2001 | SESE | | [K001079](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K001079.md) | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO | Arjo, Inc. | May 1, 2000 | SESE | | [K993872](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K993872.md) | VANNA BATHING SYSTEM | Vancare, Inc. | Feb 16, 2000 | SESE | | [K992779](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K992779.md) | A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM | Medi-Man Rehabilitation Products, Inc. | Jan 13, 2000 | SESE | | [K991184](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K991184.md) | HYDROTONE-THERMAL CAPSULE SYSTEM | Nats Corp. | Jun 23, 1999 | SESE | | [K980909](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K980909.md) | VICHY SHOWER | Bouvier Hydro, Inc. | Aug 11, 1998 | SESE | | [K980920](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K980920.md) | EQUINOXE | Bouvier Hydro, Inc. | Jul 16, 1998 | SESE | | [K974321](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K974321.md) | HYDROTONE | North American Technical Services Corp. | Jun 22, 1998 | SESE | | [K980033](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K980033.md) | FERNO HEALTHCARE RECLINE-A-BATH 2 | Ferno-Washington, Inc. | Apr 21, 1998 | SESE | | [K980769](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K980769.md) | WINDMERE MODEL DS-2 FOOT BATH | Windmere Corp. | Mar 27, 1998 | SESE | | [K971593](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K971593.md) | SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT | The Silcraft Corp. | Feb 26, 1998 | SESE | | [K971592](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K971592.md) | XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM | The Silcraft Corp. | Feb 26, 1998 | SESE | | [K964926](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K964926.md) | BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC | Joerns Healthcare, Inc. | Nov 3, 1997 | SESE | | [K952442](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K952442.md) | FREEDOM BATH | Grand Traverse Technologies | Nov 2, 1995 | SESE | | [K930665](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K930665.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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