Product code ILJ— Physical Medicine
A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
- Classification name
- Bath, Hydro-Massage
- Device class
- Class 2
- Regulation
- 21 CFR 890.5100
- Advisory panel
- Physical Medicine
- Total cleared
- 73
- First cleared
- Most recent
Market context for product code ILJ
FDA has cleared devices under product code ILJ between 1977 and 2011, filed by 50 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2011
- 2009
- 2006
- 2004
- 2001
- 2000
- 1999
- 1998
- 1997
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
Top applicants under product code ILJ
Adverse events under product code ILJ
product code ILJ- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code ILJ
- K110994 — PARKER 500
- K082951 — IMMERSION HYDROBATH
- K052479 — MBATH 1000 (60)
- K040772 — PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
- K012057 — CASCADE BATH, MODEL 6900
- K012061 — SUPERIOR BATH, MODEL 6300
- K001079 — RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
- K993872 — VANNA BATHING SYSTEM
- K992779 — A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
- K991184 — HYDROTONE-THERMAL CAPSULE SYSTEM
- K980909 — VICHY SHOWER
- K980920 — EQUINOXE
- K974321 — HYDROTONE
- K980033 — FERNO HEALTHCARE RECLINE-A-BATH 2
- K980769 — WINDMERE MODEL DS-2 FOOT BATH
- K971592 — XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
- K971593 — SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
- K964926 — BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
- K952442 — FREEDOM BATH
- K930665 — CENTURY BATHING SYSTEM
- K930820 — AQUADYNE
- K930821 — THERA-FIT
- K925195 — MALIBU BATHING SYSTEM
- K925193 — AQUACISER II
- K930624 — SANITAS WHIRPOOL BATHING SYSTEM
- K930096 — NO CROSS CONTAM HYDROTHERAPY TANK LINER
- K923637 — ARJO-CENTURY ARM AND LEG TANK SYSTEM
- K923617 — FULL MOVEMENT THERAPY SYSTEMS
- K923159 — ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS
- K922160 — AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS
- K914125 — FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403
- K911758 — AMISH COUNTRY SPA
- K911551 — SHOWER MINI RD-7 SANITARY WASHER
- K905599 — JETTA JR. HYDRO MASSAGE
- K910607 — PACIFIC MARQUIS SPA
- K904106 — SPA SHELL
- K902603 — LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH
- K890548 — AQUACISER SYSTEM
- K890308 — HYDROTONE I
- K883187 — SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM
- K883308 — PARKER BATHING SYSTEM
- K880355 — MODEL 938 BATHING SYSTEM
- K872327 — WHIRLPOOL AERATOR WB700, WB800, WB900, WB975
- K864721 — CRYOTHERM
- K861218 — AQUA ARK, IMMERSION HYDROBATH
- K854861 — SETMA HYGIA BATH MODEL ST 7200
- K854263 — SETMA FHT, MODEL ST 8130
- K853163 — SETMA VHT
- K844064 — MEDO BUBBLE BATH MA-80, 400, 600 & 700
- K842941 — MULTIPLE PLANETAMED; PLANETA HYDROMASS
- K842641 — HYDRO/BUBBLE BATH DEVICE 300
- K842642 — BALSAN 700
- K842643 — MASSAPED
- K841954 — OASIS CLUB HYDROMASSAGE
- K841397 — BURN BATH
- K840282 — OVERHEAD WHIRLPOOL HAND SPA BRAND
- K833839 — BIOTHERM
- K821809 — THERMOFONTE AIR MESSAGE BATH
- K812033 — THE LYMAN BATHCHAIR
- K811903 — CENTURY HYDROTHERAPY PUMP
- K811904 — CENTURY HYDRO-SAN THERAPY TANK
- K810034 — FOOT BATHS & HAND MASSAGERS
- K802335 — WHIRLPOOL BATHING UNIT-#2001
- K792641 — HYDRO PULSE MASSAGE
- K791718 — SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL
- K791603 — GILLETTE CORDLESS WHIRLPOOL
- K771966 — VIBRO BATH MODEL FS-1
- K771969 — TURBO-JET MODEL 76
- K771970 — WHIRLPOOL BATH MODEL 50
- K771965 — WHIRLPOOL BATH MODEL 2274
- K771967 — WHIRLPOOL BATH MODEL 2270
- K771968 — WHIRLPOOL BATH MODEL 2273
- K771971 — HYDROMASSAGE EQUIP. MODEL 1000
Data sourced from openFDA. This site is unofficial and independent of the FDA.