FDA Product Code
FDA Product Code ILJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5100
510(k) Clearances — 73 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K110994 | PARKER 500 | Arjohuntleigh, Inc. | 2011-07-06 | Abbreviated | PDF ↗ |
| K082951 | IMMERSION HYDROBATH | Arjo Hospital Equipment AB | 2009-04-08 | Traditional | PDF ↗ |
| K052479 | MBATH 1000 (60) | Enneking Medical, Inc. | 2006-01-26 | Traditional | PDF ↗ |
| K040772 | PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM | Penner Manufacturing, Inc. | 2004-04-05 | Traditional | PDF ↗ |
| K012061 | SUPERIOR BATH, MODEL 6300 | Penner Manufacturing, Inc. | 2001-07-19 | Traditional | PDF ↗ |
| K012057 | CASCADE BATH, MODEL 6900 | Penner Manufacturing, Inc. | 2001-07-19 | Traditional | PDF ↗ |
| K001079 | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO | Arjo, Inc. | 2000-05-01 | Traditional | PDF ↗ |
| K993872 | VANNA BATHING SYSTEM | Vancare, Inc. | 2000-02-16 | Traditional | PDF ↗ |
| K992779 | A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM | Medi-Man Rehabilitation Products, Inc. | 2000-01-13 | Traditional | PDF ↗ |
| K991184 | HYDROTONE-THERMAL CAPSULE SYSTEM | Nats Corp. | 1999-06-23 | Abbreviated | PDF ↗ |
| K980909 | VICHY SHOWER | Bouvier Hydro, Inc. | 1998-08-11 | Traditional | PDF ↗ |
| K980920 | EQUINOXE | Bouvier Hydro, Inc. | 1998-07-16 | Traditional | PDF ↗ |
| K974321 | HYDROTONE | North American Technical Services Corp. | 1998-06-22 | Traditional | PDF ↗ |
| K980033 | FERNO HEALTHCARE RECLINE-A-BATH 2 | Ferno-Washington, Inc. | 1998-04-21 | Traditional | PDF ↗ |
| K980769 | WINDMERE MODEL DS-2 FOOT BATH | Windmere Corp. | 1998-03-27 | Traditional | PDF ↗ |
| K971593 | SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT | The Silcraft Corp. | 1998-02-26 | Traditional | PDF ↗ |
| K971592 | XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM | The Silcraft Corp. | 1998-02-26 | Traditional | PDF ↗ |
| K964926 | BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC | Joerns Healthcare, Inc. | 1997-11-03 | Traditional | PDF ↗ |
| K952442 | FREEDOM BATH | Grand Traverse Technologies | 1995-11-02 | Traditional | PDF ↗ |
| K930665 | CENTURY BATHING SYSTEM | Arjo-Century, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K930820 | AQUADYNE | Aquatherapy Systems, Inc. | 1994-11-09 | Traditional | PDF ↗ |
| K930821 | THERA-FIT | Aquatherapy Systems, Inc. | 1994-11-09 | Traditional | PDF ↗ |
| K925195 | MALIBU BATHING SYSTEM | Medi-Man Rehabilitation Products, Inc. | 1994-10-17 | Traditional | PDF ↗ |
| K925193 | AQUACISER II | Aquaciser, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K930624 | SANITAS WHIRPOOL BATHING SYSTEM | Dutton-Lainson Co. | 1994-07-01 | Traditional | PDF ↗ |
| K930096 | NO CROSS CONTAM HYDROTHERAPY TANK LINER | Land and Sky Mfg., Inc. | 1994-06-30 | Traditional | PDF ↗ |
| K923637 | ARJO-CENTURY ARM AND LEG TANK SYSTEM | Arjo-Century, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K923617 | FULL MOVEMENT THERAPY SYSTEMS | Arjo-Century, Inc. | 1992-11-09 | Traditional | PDF ↗ |
| K923159 | ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS | Arjo-Century, Inc. | 1992-08-06 | Traditional | PDF ↗ |
| K922160 | AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS | Aquamotion, Inc. | 1992-06-19 | Traditional | PDF ↗ |
| K914125 | FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403 | Ferno | 1991-10-25 | Traditional | PDF ↗ |
| K911758 | AMISH COUNTRY SPA | Fox Pool Corp. | 1991-10-02 | Traditional | PDF ↗ |
| K911551 | SHOWER MINI RD-7 SANITARY WASHER | Aiex USA , Ltd. | 1991-09-06 | Traditional | PDF ↗ |
| K905599 | JETTA JR. HYDRO MASSAGE | Jetta Products, Inc. | 1991-03-26 | Traditional | PDF ↗ |
| K910607 | PACIFIC MARQUIS SPA | Marquis International , Ltd. | 1991-02-21 | Traditional | PDF ↗ |
| K904106 | SPA SHELL | Century Manufacturing Co. | 1990-09-18 | Traditional | PDF ↗ |
| K902603 | LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH | Unique Bathing Supplies, Inc. | 1990-06-29 | Traditional | PDF ↗ |
| K890548 | AQUACISER SYSTEM | Aquaciser, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890308 | HYDROTONE I | Hydrotonics Therapy Corp. | 1989-01-31 | Traditional | PDF ↗ |
| K883187 | SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM | Intl. Health Technology, Inc. | 1988-10-27 | Traditional | PDF ↗ |
| K883308 | PARKER BATHING SYSTEM | Mid-Canada Medical | 1988-09-22 | Traditional | PDF ↗ |
| K880355 | MODEL 938 BATHING SYSTEM | Ferno Ille-Forge | 1988-02-16 | Traditional | PDF ↗ |
| K872327 | WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 | Associated Mills, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K864721 | CRYOTHERM | Grimm Scientific Industries, Inc. | 1987-02-04 | Traditional | PDF ↗ |
| K861218 | AQUA ARK, IMMERSION HYDROBATH | Aqua Ark, Inc. | 1986-04-18 | Traditional | PDF ↗ |
| K854861 | SETMA HYGIA BATH MODEL ST 7200 | Setma, Inc. | 1986-01-03 | Traditional | PDF ↗ |
| K854263 | SETMA FHT, MODEL ST 8130 | Setma, Inc. | 1985-11-13 | Traditional | PDF ↗ |
| K853163 | SETMA VHT | Setma, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K844064 | MEDO BUBBLE BATH MA-80, 400, 600 & 700 | Medo U.S.A., Inc. | 1985-01-23 | Traditional | PDF ↗ |
| K842941 | MULTIPLE PLANETAMED;PLANETA HYDROMASS | Planeta Hausgeraete KG | 1984-08-03 | Traditional | PDF ↗ |
| K842643 | MASSAPED | Heddernheimer Metallwarenfabrik GmbH | 1984-07-25 | Traditional | PDF ↗ |
| K842642 | BALSAN 700 | Heddernheimer Metallwarenfabrik GmbH | 1984-07-25 | Traditional | PDF ↗ |
| K842641 | HYDRO/BUBBLE BATH DEVICE 300 | Heddernheimer Metallwarenfabrik GmbH | 1984-07-25 | Traditional | PDF ↗ |
| K841954 | OASIS CLUB HYDROMASSAGE | Prexcor America, Inc. | 1984-05-23 | Traditional | PDF ↗ |
| K841397 | BURN BATH | Setma, Inc. | 1984-05-18 | Traditional | PDF ↗ |
| K840282 | OVERHEAD WHIRLPOOL HAND SPA BRAND | Priest Enterprises, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833839 | BIOTHERM | Trileen, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K821809 | THERMOFONTE AIR MESSAGE BATH | Greenfields | 1982-07-23 | Traditional | PDF ↗ |
| K812033 | THE LYMAN BATHCHAIR | The Lyman Bathchair Corp. | 1981-08-13 | Traditional | PDF ↗ |
| K811904 | CENTURY HYDRO-SAN THERAPY TANK | Century Manufacturing Co. | 1981-07-20 | Traditional | PDF ↗ |
| K811903 | CENTURY HYDROTHERAPY PUMP | Century Manufacturing Co. | 1981-07-20 | Traditional | PDF ↗ |
| K810034 | FOOT BATHS & HAND MASSAGERS | Associated Mills, Inc. | 1981-01-15 | Traditional | PDF ↗ |
| K802335 | WHIRLPOOL BATHING UNIT-#2001 | Aqua Care Corp. | 1980-10-10 | Traditional | PDF ↗ |
| K792641 | HYDRO PULSE MASSAGE | Hydro-Pulse Research, Inc. | 1980-01-28 | Traditional | PDF ↗ |
| K791718 | SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL | Universal-Kundle Corp. | 1979-10-04 | Traditional | PDF ↗ |
| K791603 | GILLETTE CORDLESS WHIRLPOOL | The Gillette Company | 1979-09-07 | Traditional | PDF ↗ |
| K771966 | VIBRO BATH MODEL FS-1 | Dazey Products Co. | 1977-11-02 | Traditional | PDF ↗ |
| K771970 | WHIRLPOOL BATH MODEL 50 | Dazey Products Co. | 1977-11-02 | Traditional | PDF ↗ |
| K771969 | TURBO-JET MODEL 76 | Dazey Products Co. | 1977-11-02 | Traditional | PDF ↗ |
| K771968 | WHIRLPOOL BATH MODEL 2273 | Dazey Products Co. | 1977-10-28 | Traditional | PDF ↗ |
| K771965 | WHIRLPOOL BATH MODEL 2274 | Dozey Products Co. | 1977-10-28 | Traditional | PDF ↗ |
| K771967 | WHIRLPOOL BATH MODEL 2270 | Dazey Products Co. | 1977-10-28 | Traditional | PDF ↗ |
| K771971 | HYDROMASSAGE EQUIP. MODEL 1000 | Dazey Products Co. | 1977-10-21 | Traditional | PDF ↗ |
Product code ILJ · Class II · Physical Medicine. Data: openFDA.