Product code ILJ
- Device name
- Bath, Hydro-Massage
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5100
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110994 | PARKER 500 | Arjohuntleigh, Inc. | 2011-07-06 |
| K082951 | IMMERSION HYDROBATH | Arjo Hospital Equipment AB | 2009-04-08 |
| K052479 | MBATH 1000 (60) | Enneking Medical, Inc. | 2006-01-26 |
| K040772 | PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM | Penner Manufacturing, Inc. | 2004-04-05 |
| K012057 | CASCADE BATH, MODEL 6900 | Penner Manufacturing, Inc. | 2001-07-19 |
| K012061 | SUPERIOR BATH, MODEL 6300 | Penner Manufacturing, Inc. | 2001-07-19 |
| K001079 | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO | Arjo, Inc. | 2000-05-01 |
| K993872 | VANNA BATHING SYSTEM | Vancare, Inc. | 2000-02-16 |
| K992779 | A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM | Medi-Man Rehabilitation Products, Inc. | 2000-01-13 |
| K991184 | HYDROTONE-THERMAL CAPSULE SYSTEM | Nats Corp. | 1999-06-23 |
| K980909 | VICHY SHOWER | Bouvier Hydro, Inc. | 1998-08-11 |
| K980920 | EQUINOXE | Bouvier Hydro, Inc. | 1998-07-16 |
| K974321 | HYDROTONE | North American Technical Services Corp. | 1998-06-22 |
| K980033 | FERNO HEALTHCARE RECLINE-A-BATH 2 | Ferno-Washington, Inc. | 1998-04-21 |
| K980769 | WINDMERE MODEL DS-2 FOOT BATH | Windmere Corp. | 1998-03-27 |
| K971593 | SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT | The Silcraft Corp. | 1998-02-26 |
| K971592 | XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM | The Silcraft Corp. | 1998-02-26 |
| K964926 | BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC | Joerns Healthcare, Inc. | 1997-11-03 |
| K952442 | FREEDOM BATH | Grand Traverse Technologies | 1995-11-02 |
| K930665 | CENTURY BATHING SYSTEM | Arjo-Century, Inc. | 1995-08-28 |
| K930820 | AQUADYNE | Aquatherapy Systems, Inc. | 1994-11-09 |
| K930821 | THERA-FIT | Aquatherapy Systems, Inc. | 1994-11-09 |
| K925195 | MALIBU BATHING SYSTEM | Medi-Man Rehabilitation Products, Inc. | 1994-10-17 |
| K925193 | AQUACISER II | Aquaciser, Inc. | 1994-08-26 |
| K930624 | SANITAS WHIRPOOL BATHING SYSTEM | Dutton-Lainson Co. | 1994-07-01 |
| K930096 | NO CROSS CONTAM HYDROTHERAPY TANK LINER | Land and Sky Mfg., Inc. | 1994-06-30 |
| K923637 | ARJO-CENTURY ARM AND LEG TANK SYSTEM | Arjo-Century, Inc. | 1993-02-12 |
| K923617 | FULL MOVEMENT THERAPY SYSTEMS | Arjo-Century, Inc. | 1992-11-09 |
| K923159 | ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS | Arjo-Century, Inc. | 1992-08-06 |
| K922160 | AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS | Aquamotion, Inc. | 1992-06-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199874983844 | Apollo Corp | APOLLO CORP. | 2025-11-17 |
| 05059441310242 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441310235 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441310228 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441310211 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441310204 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441310198 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441310181 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441310174 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441306122 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441306115 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441306108 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441268307 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441268291 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441268277 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219705 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219699 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219682 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219675 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219668 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219651 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219644 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219637 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219620 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219613 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219606 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219590 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219583 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 05059441219576 | Symbliss Bath | Arjohuntleigh AB | 2024-09-25 |
| 00866595000241 | Apollo Corp | APOLLO CORP. | 2020-06-05 |