Atlas FDA

ILJ

73 FDA 510(k) clearances · Product code

38 daysmedian time to decision
329 days90th percentile
73clearances measured

FDA profile

Official device name
Bath, Hydro-Massage
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5100
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2015: 72 · 2016: 57 · 2017: 26 · 2018: 21 · 2019: 22 · 2020: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PARKER 500 (K110994)Arjohuntleigh, Inc.2011-07-06
IMMERSION HYDROBATH (K082951)Arjo Hospital Equipment AB2009-04-08
MBATH 1000 (60) (K052479)Enneking Medical, Inc.2006-01-26
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM (K040772)Penner Manufacturing, Inc.2004-04-05
SUPERIOR BATH, MODEL 6300 (K012061)Penner Manufacturing, Inc.2001-07-19
CASCADE BATH, MODEL 6900 (K012057)Penner Manufacturing, Inc.2001-07-19
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO (K001079)Arjo, Inc.2000-05-01
VANNA BATHING SYSTEM (K993872)Vancare, Inc.2000-02-16
A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM (K992779)Medi-Man Rehabilitation Products, Inc.2000-01-13
HYDROTONE-THERMAL CAPSULE SYSTEM (K991184)Nats Corp.1999-06-23
VICHY SHOWER (K980909)Bouvier Hydro, Inc.1998-08-11
EQUINOXE (K980920)Bouvier Hydro, Inc.1998-07-16
HYDROTONE (K974321)North American Technical Services Corp.1998-06-22
FERNO HEALTHCARE RECLINE-A-BATH 2 (K980033)Ferno-Washington, Inc.1998-04-21
WINDMERE MODEL DS-2 FOOT BATH (K980769)Windmere Corp.1998-03-27
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT (K971593)The Silcraft Corp.1998-02-26
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM (K971592)The Silcraft Corp.1998-02-26
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC (K964926)Joerns Healthcare, Inc.1997-11-03
FREEDOM BATH (K952442)Grand Traverse Technologies1995-11-02
CENTURY BATHING SYSTEM (K930665)Arjo-Century, Inc.1995-08-28
AQUADYNE (K930820)Aquatherapy Systems, Inc.1994-11-09
THERA-FIT (K930821)Aquatherapy Systems, Inc.1994-11-09
MALIBU BATHING SYSTEM (K925195)Medi-Man Rehabilitation Products, Inc.1994-10-17
AQUACISER II (K925193)Aquaciser, Inc.1994-08-26
SANITAS WHIRPOOL BATHING SYSTEM (K930624)Dutton-Lainson Co.1994-07-01
NO CROSS CONTAM HYDROTHERAPY TANK LINER (K930096)Land and Sky Mfg., Inc.1994-06-30
ARJO-CENTURY ARM AND LEG TANK SYSTEM (K923637)Arjo-Century, Inc.1993-02-12
FULL MOVEMENT THERAPY SYSTEMS (K923617)Arjo-Century, Inc.1992-11-09
ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS (K923159)Arjo-Century, Inc.1992-08-06
AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS (K922160)Aquamotion, Inc.1992-06-19
FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403 (K914125)Ferno1991-10-25
AMISH COUNTRY SPA (K911758)Fox Pool Corp.1991-10-02
SHOWER MINI RD-7 SANITARY WASHER (K911551)Aiex USA , Ltd.1991-09-06
JETTA JR. HYDRO MASSAGE (K905599)Jetta Products, Inc.1991-03-26
PACIFIC MARQUIS SPA (K910607)Marquis International , Ltd.1991-02-21
SPA SHELL (K904106)Century Manufacturing Co.1990-09-18
LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH (K902603)Unique Bathing Supplies, Inc.1990-06-29
AQUACISER SYSTEM (K890548)Aquaciser, Inc.1989-02-13
HYDROTONE I (K890308)Hydrotonics Therapy Corp.1989-01-31
SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM (K883187)Intl. Health Technology, Inc.1988-10-27
PARKER BATHING SYSTEM (K883308)Mid-Canada Medical1988-09-22
MODEL 938 BATHING SYSTEM (K880355)Ferno Ille-Forge1988-02-16
WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 (K872327)Associated Mills, Inc.1987-09-04
CRYOTHERM (K864721)Grimm Scientific Industries, Inc.1987-02-04
AQUA ARK, IMMERSION HYDROBATH (K861218)Aqua Ark, Inc.1986-04-18
SETMA HYGIA BATH MODEL ST 7200 (K854861)Setma, Inc.1986-01-03
SETMA FHT, MODEL ST 8130 (K854263)Setma, Inc.1985-11-13
SETMA VHT (K853163)Setma, Inc.1985-11-05
MEDO BUBBLE BATH MA-80, 400, 600 & 700 (K844064)Medo U.S.A., Inc.1985-01-23
MULTIPLE PLANETAMED;PLANETA HYDROMASS (K842941)Planeta Hausgeraete KG1984-08-03
MASSAPED (K842643)Heddernheimer Metallwarenfabrik GmbH1984-07-25
BALSAN 700 (K842642)Heddernheimer Metallwarenfabrik GmbH1984-07-25
HYDRO/BUBBLE BATH DEVICE 300 (K842641)Heddernheimer Metallwarenfabrik GmbH1984-07-25
OASIS CLUB HYDROMASSAGE (K841954)Prexcor America, Inc.1984-05-23
BURN BATH (K841397)Setma, Inc.1984-05-18
OVERHEAD WHIRLPOOL HAND SPA BRAND (K840282)Priest Enterprises, Inc.1984-02-04
BIOTHERM (K833839)Trileen, Inc.1983-12-27
THERMOFONTE AIR MESSAGE BATH (K821809)Greenfields1982-07-23
THE LYMAN BATHCHAIR (K812033)The Lyman Bathchair Corp.1981-08-13
CENTURY HYDROTHERAPY PUMP (K811903)Century Manufacturing Co.1981-07-20
CENTURY HYDRO-SAN THERAPY TANK (K811904)Century Manufacturing Co.1981-07-20
FOOT BATHS & HAND MASSAGERS (K810034)Associated Mills, Inc.1981-01-15
WHIRLPOOL BATHING UNIT-#2001 (K802335)Aqua Care Corp.1980-10-10
HYDRO PULSE MASSAGE (K792641)Hydro-Pulse Research, Inc.1980-01-28
SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL (K791718)Universal-Kundle Corp.1979-10-04
GILLETTE CORDLESS WHIRLPOOL (K791603)The Gillette Company1979-09-07
VIBRO BATH MODEL FS-1 (K771966)Dazey Products Co.1977-11-02
TURBO-JET MODEL 76 (K771969)Dazey Products Co.1977-11-02
WHIRLPOOL BATH MODEL 50 (K771970)Dazey Products Co.1977-11-02
WHIRLPOOL BATH MODEL 2270 (K771967)Dazey Products Co.1977-10-28
WHIRLPOOL BATH MODEL 2274 (K771965)Dozey Products Co.1977-10-28
WHIRLPOOL BATH MODEL 2273 (K771968)Dazey Products Co.1977-10-28
HYDROMASSAGE EQUIP. MODEL 1000 (K771971)Dazey Products Co.1977-10-21

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