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Bath, Hydro-Massage

FDA product code ILJ · 73 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.5100
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-10-21 – 2011-07-06

ILJ 2011-07-06

PARKER 500

Applicant Arjohuntleigh, Inc.

K number K110994

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ILJ 2009-04-08

IMMERSION HYDROBATH

Applicant Arjo Hospital Equipment AB

K number K082951

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ILJ 2006-01-26

MBATH 1000 (60)

Applicant Enneking Medical, Inc.

K number K052479

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ILJ 2004-04-05

PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM

Applicant Penner Manufacturing, Inc.

K number K040772

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ILJ 2001-07-19

SUPERIOR BATH, MODEL 6300

Applicant Penner Manufacturing, Inc.

K number K012061

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ILJ 2001-07-19

CASCADE BATH, MODEL 6900

Applicant Penner Manufacturing, Inc.

K number K012057

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ILJ 2000-05-01

RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO

Applicant Arjo, Inc.

K number K001079

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ILJ 2000-02-16

VANNA BATHING SYSTEM

Applicant Vancare, Inc.

K number K993872

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ILJ 2000-01-13

A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM

Applicant Medi-Man Rehabilitation Products, Inc.

K number K992779

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ILJ 1999-06-23

HYDROTONE-THERMAL CAPSULE SYSTEM

Applicant Nats Corp.

K number K991184

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ILJ 1998-08-11

VICHY SHOWER

Applicant Bouvier Hydro, Inc.

K number K980909

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ILJ 1998-07-16

EQUINOXE

Applicant Bouvier Hydro, Inc.

K number K980920

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ILJ 1998-06-22

HYDROTONE

Applicant North American Technical Services Corp.

K number K974321

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ILJ 1998-04-21

FERNO HEALTHCARE RECLINE-A-BATH 2

Applicant Ferno-Washington, Inc.

K number K980033

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ILJ 1998-03-27

WINDMERE MODEL DS-2 FOOT BATH

Applicant Windmere Corp.

K number K980769

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ILJ 1998-02-26

SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT

Applicant The Silcraft Corp.

K number K971593

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ILJ 1998-02-26

XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM

Applicant The Silcraft Corp.

K number K971592

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ILJ 1997-11-03

BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC

Applicant Joerns Healthcare, Inc.

K number K964926

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ILJ 1995-11-02

FREEDOM BATH

Applicant Grand Traverse Technologies

K number K952442

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ILJ 1995-08-28

CENTURY BATHING SYSTEM

Applicant Arjo-Century, Inc.

K number K930665

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ILJ 1994-11-09

THERA-FIT

Applicant Aquatherapy Systems, Inc.

K number K930821

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ILJ 1994-11-09

AQUADYNE

Applicant Aquatherapy Systems, Inc.

K number K930820

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ILJ 1994-10-17

MALIBU BATHING SYSTEM

Applicant Medi-Man Rehabilitation Products, Inc.

K number K925195

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ILJ 1994-08-26

AQUACISER II

Applicant Aquaciser, Inc.

K number K925193

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ILJ 1994-07-01

SANITAS WHIRPOOL BATHING SYSTEM

Applicant Dutton-Lainson Co.

K number K930624

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ILJ 1994-06-30

NO CROSS CONTAM HYDROTHERAPY TANK LINER

Applicant Land and Sky Mfg., Inc.

K number K930096

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ILJ 1993-02-12

ARJO-CENTURY ARM AND LEG TANK SYSTEM

Applicant Arjo-Century, Inc.

K number K923637

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ILJ 1992-11-09

FULL MOVEMENT THERAPY SYSTEMS

Applicant Arjo-Century, Inc.

K number K923617

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ILJ 1992-08-06

ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS

Applicant Arjo-Century, Inc.

K number K923159

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ILJ 1992-06-19

AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS

Applicant Aquamotion, Inc.

K number K922160

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ILJ 1991-10-25

FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403

Applicant Ferno

K number K914125

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ILJ 1991-10-02

AMISH COUNTRY SPA

Applicant Fox Pool Corp.

K number K911758

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ILJ 1991-09-06

SHOWER MINI RD-7 SANITARY WASHER

Applicant Aiex USA , Ltd.

K number K911551

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ILJ 1991-03-26

JETTA JR. HYDRO MASSAGE

Applicant Jetta Products, Inc.

K number K905599

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ILJ 1991-02-21

PACIFIC MARQUIS SPA

Applicant Marquis International , Ltd.

K number K910607

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ILJ 1990-09-18

SPA SHELL

Applicant Century Manufacturing Co.

K number K904106

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ILJ 1990-06-29

LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH

Applicant Unique Bathing Supplies, Inc.

K number K902603

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ILJ 1989-02-13

AQUACISER SYSTEM

Applicant Aquaciser, Inc.

K number K890548

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ILJ 1989-01-31

HYDROTONE I

Applicant Hydrotonics Therapy Corp.

K number K890308

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ILJ 1988-10-27

SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM

Applicant Intl. Health Technology, Inc.

K number K883187

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ILJ 1988-09-22

PARKER BATHING SYSTEM

Applicant Mid-Canada Medical

K number K883308

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ILJ 1988-02-16

MODEL 938 BATHING SYSTEM

Applicant Ferno Ille-Forge

K number K880355

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ILJ 1987-09-04

WHIRLPOOL AERATOR WB700, WB800, WB900, WB975

Applicant Associated Mills, Inc.

K number K872327

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ILJ 1987-02-04

CRYOTHERM

Applicant Grimm Scientific Industries, Inc.

K number K864721

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ILJ 1986-04-18

AQUA ARK, IMMERSION HYDROBATH

Applicant Aqua Ark, Inc.

K number K861218

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ILJ 1986-01-03

SETMA HYGIA BATH MODEL ST 7200

Applicant Setma, Inc.

K number K854861

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ILJ 1985-11-13

SETMA FHT, MODEL ST 8130

Applicant Setma, Inc.

K number K854263

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ILJ 1985-11-05

SETMA VHT

Applicant Setma, Inc.

K number K853163

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ILJ 1985-01-23

MEDO BUBBLE BATH MA-80, 400, 600 & 700

Applicant Medo U.S.A., Inc.

K number K844064

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ILJ 1984-08-03

MULTIPLE PLANETAMED;PLANETA HYDROMASS

Applicant Planeta Hausgeraete KG

K number K842941

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ILJ 1984-07-25

MASSAPED

Applicant Heddernheimer Metallwarenfabrik GmbH

K number K842643

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ILJ 1984-07-25

BALSAN 700

Applicant Heddernheimer Metallwarenfabrik GmbH

K number K842642

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ILJ 1984-07-25

HYDRO/BUBBLE BATH DEVICE 300

Applicant Heddernheimer Metallwarenfabrik GmbH

K number K842641

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ILJ 1984-05-23

OASIS CLUB HYDROMASSAGE

Applicant Prexcor America, Inc.

K number K841954

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ILJ 1984-05-18

BURN BATH

Applicant Setma, Inc.

K number K841397

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ILJ 1984-02-04

OVERHEAD WHIRLPOOL HAND SPA BRAND

Applicant Priest Enterprises, Inc.

K number K840282

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ILJ 1983-12-27

BIOTHERM

Applicant Trileen, Inc.

K number K833839

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ILJ 1982-07-23

THERMOFONTE AIR MESSAGE BATH

Applicant Greenfields

K number K821809

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ILJ 1981-08-13

THE LYMAN BATHCHAIR

Applicant The Lyman Bathchair Corp.

K number K812033

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ILJ 1981-07-20

CENTURY HYDRO-SAN THERAPY TANK

Applicant Century Manufacturing Co.

K number K811904

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ILJ 1981-07-20

CENTURY HYDROTHERAPY PUMP

Applicant Century Manufacturing Co.

K number K811903

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ILJ 1981-01-15

FOOT BATHS & HAND MASSAGERS

Applicant Associated Mills, Inc.

K number K810034

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ILJ 1980-10-10

WHIRLPOOL BATHING UNIT-#2001

Applicant Aqua Care Corp.

K number K802335

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ILJ 1980-01-28

HYDRO PULSE MASSAGE

Applicant Hydro-Pulse Research, Inc.

K number K792641

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ILJ 1979-10-04

SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL

Applicant Universal-Kundle Corp.

K number K791718

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ILJ 1979-09-07

GILLETTE CORDLESS WHIRLPOOL

Applicant The Gillette Company

K number K791603

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ILJ 1977-11-02

WHIRLPOOL BATH MODEL 50

Applicant Dazey Products Co.

K number K771970

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ILJ 1977-11-02

TURBO-JET MODEL 76

Applicant Dazey Products Co.

K number K771969

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ILJ 1977-11-02

VIBRO BATH MODEL FS-1

Applicant Dazey Products Co.

K number K771966

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ILJ 1977-10-28

WHIRLPOOL BATH MODEL 2273

Applicant Dazey Products Co.

K number K771968

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ILJ 1977-10-28

WHIRLPOOL BATH MODEL 2270

Applicant Dazey Products Co.

K number K771967

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ILJ 1977-10-28

WHIRLPOOL BATH MODEL 2274

Applicant Dozey Products Co.

K number K771965

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ILJ 1977-10-21

HYDROMASSAGE EQUIP. MODEL 1000

Applicant Dazey Products Co.

K number K771971

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