ILJ — Bath, Hydro-Massage Class II
FDA product code ILJ covers "Bath, Hydro-Massage", a Class II medical device regulated under 21 CFR 890.5100. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ILJ
- Device Class
- Class II
- Regulation Number
- 890.5100
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110994 | arjohuntleigh | PARKER 500 | July 6, 2011 |
| K082951 | arjo hospital equipment | IMMERSION HYDROBATH | April 8, 2009 |
| K052479 | enneking medical | MBATH 1000 (60) | January 26, 2006 |
| K040772 | penner manufacturing | PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM | April 5, 2004 |
| K012057 | penner manufacturing | CASCADE BATH, MODEL 6900 | July 19, 2001 |
| K012061 | penner manufacturing | SUPERIOR BATH, MODEL 6300 | July 19, 2001 |
| K001079 | arjo | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO | May 1, 2000 |
| K993872 | vancare | VANNA BATHING SYSTEM | February 16, 2000 |
| K992779 | medi-man rehabilitation products | A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM | January 13, 2000 |
| K991184 | nats | HYDROTONE-THERMAL CAPSULE SYSTEM | June 23, 1999 |
| K980909 | bouvier hydro | VICHY SHOWER | August 11, 1998 |
| K980920 | bouvier hydro | EQUINOXE | July 16, 1998 |
| K974321 | north american technical services | HYDROTONE | June 22, 1998 |
| K980033 | ferno-washington | FERNO HEALTHCARE RECLINE-A-BATH 2 | April 21, 1998 |
| K980769 | windmere | WINDMERE MODEL DS-2 FOOT BATH | March 27, 1998 |
| K971592 | silcraft | XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM | February 26, 1998 |
| K971593 | silcraft | SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINF | February 26, 1998 |
| K964926 | joerns healthcare | BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED H | November 3, 1997 |
| K952442 | grand traverse technologies | FREEDOM BATH | November 2, 1995 |
| K930665 | arjo-century | CENTURY BATHING SYSTEM | August 28, 1995 |