Product Code: ILJ FDA class 2 21 CFR 890.5100

Bath, Hydro-Massage

Physical Medicine

A Hydro-Massage Bath is a powered hydrotherapy device used in Physical Medicine that combines water immersion with mechanical agitation or water jets to apply therapeutic massage to the body, used for relaxation, pain relief, wound care, and musculoskeletal rehabilitation. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILJ, regulated under 21 CFR 890.5100, within the Physical Medicine medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: ILJ
Device Class: FDA class 2
Regulation Number: 890.5100
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 73 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K110994	PARKER 500	Jul 06, 2011	Substantially Equivalent	ARJOHUNTLEIGH INC
K082951	IMMERSION HYDROBATH	Apr 08, 2009	Substantially Equivalent	ARJO HOSPITAL EQUIPMENT AB
K052479	MBATH 1000 (60)	Jan 26, 2006	Substantially Equivalent	ENNEKING MEDICAL INC.
K040772	PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM	Apr 05, 2004	Substantially Equivalent	PENNER MANUFACTURING, INC.
K012061	SUPERIOR BATH, MODEL 6300	Jul 19, 2001	Substantially Equivalent	PENNER MANUFACTURING, INC.
K012057	CASCADE BATH, MODEL 6900	Jul 19, 2001	Substantially Equivalent	PENNER MANUFACTURING, INC.
K001079	RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO	May 01, 2000	Substantially Equivalent	ARJO, INC.
K993872	VANNA BATHING SYSTEM	Feb 16, 2000	Substantially Equivalent	VANCARE, INC.
K992779	A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM	Jan 13, 2000	Substantially Equivalent	MEDI-MAN REHABILITATION PRODUCTS, INC.
K991184	HYDROTONE-THERMAL CAPSULE SYSTEM	Jun 23, 1999	Substantially Equivalent	NATS CORP.
K980909	VICHY SHOWER	Aug 11, 1998	Substantially Equivalent	BOUVIER HYDRO, INC.
K980920	EQUINOXE	Jul 16, 1998	Substantially Equivalent	BOUVIER HYDRO, INC.
K974321	HYDROTONE	Jun 22, 1998	Substantially Equivalent	NORTH AMERICAN TECHNICAL SERVICES CORP.
K980033	FERNO HEALTHCARE RECLINE-A-BATH 2	Apr 21, 1998	Substantially Equivalent	FERNO-WASHINGTON, INC.
K980769	WINDMERE MODEL DS-2 FOOT BATH	Mar 27, 1998	Substantially Equivalent	WINDMERE CORP.
K971593	SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT	Feb 26, 1998	Substantially Equivalent	THE SILCRAFT CORP.
K971592	XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM	Feb 26, 1998	Substantially Equivalent	THE SILCRAFT CORP.
K964926	BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC	Nov 03, 1997	Substantially Equivalent	JOERNS HEALTHCARE, INC.
K952442	FREEDOM BATH	Nov 02, 1995	Substantially Equivalent	GRAND TRAVERSE TECHNOLOGIES
K930665	CENTURY BATHING SYSTEM	Aug 28, 1995	Substantially Equivalent	ARJO-CENTURY, INC.
K930821	THERA-FIT	Nov 09, 1994	Substantially Equivalent	AQUATHERAPY SYSTEMS, INC.
K930820	AQUADYNE	Nov 09, 1994	Substantially Equivalent	AQUATHERAPY SYSTEMS, INC.
K925195	MALIBU BATHING SYSTEM	Oct 17, 1994	Substantially Equivalent	MEDI-MAN REHABILITATION PRODUCTS, INC.
K925193	AQUACISER II	Aug 26, 1994	Substantially Equivalent	AQUACISER, INC.
K930624	SANITAS WHIRPOOL BATHING SYSTEM	Jul 01, 1994	Substantially Equivalent	DUTTON-LAINSON CO.
K930096	NO CROSS CONTAM HYDROTHERAPY TANK LINER	Jun 30, 1994	Substantially Equivalent	LAND AND SKY MFG., INC.
K923637	ARJO-CENTURY ARM AND LEG TANK SYSTEM	Feb 12, 1993	Substantially Equivalent	ARJO-CENTURY, INC.
K923617	FULL MOVEMENT THERAPY SYSTEMS	Nov 09, 1992	Substantially Equivalent	ARJO-CENTURY, INC.
K923159	ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS	Aug 06, 1992	Substantially Equivalent	ARJO-CENTURY, INC.
K922160	AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS	Jun 19, 1992	Substantially Equivalent	AQUAMOTION, INC.
K914125	FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403	Oct 25, 1991	Substantially Equivalent	FERNO
K911758	AMISH COUNTRY SPA	Oct 02, 1991	Substantially Equivalent	FOX POOL CORP.
K911551	SHOWER MINI RD-7 SANITARY WASHER	Sep 06, 1991	Substantially Equivalent	AIEX USA LTD.
K905599	JETTA JR. HYDRO MASSAGE	Mar 26, 1991	Substantially Equivalent	JETTA PRODUCTS, INC.
K910607	PACIFIC MARQUIS SPA	Feb 21, 1991	Substantially Equivalent	MARQUIS INTERNATIONAL LTD.
K904106	SPA SHELL	Sep 18, 1990	Substantially Equivalent	CENTURY MANUFACTURING CO.
K902603	LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH	Jun 29, 1990	Substantially Equivalent	UNIQUE BATHING SUPPLIES, INC.
K890548	AQUACISER SYSTEM	Feb 13, 1989	Substantially Equivalent	AQUACISER, INC.
K890308	HYDROTONE I	Jan 31, 1989	Substantially Equivalent	HYDROTONICS THERAPY CORP.
K883187	SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM	Oct 27, 1988	Substantially Equivalent	INTL. HEALTH TECHNOLOGY, INC.
K883308	PARKER BATHING SYSTEM	Sep 22, 1988	Substantially Equivalent	MID-CANADA MEDICAL
K880355	MODEL 938 BATHING SYSTEM	Feb 16, 1988	Substantially Equivalent	FERNO ILLE-FORGE
K872327	WHIRLPOOL AERATOR WB700, WB800, WB900, WB975	Sep 04, 1987	Substantially Equivalent	ASSOCIATED MILLS, INC.
K864721	CRYOTHERM	Feb 04, 1987	Substantially Equivalent	GRIMM SCIENTIFIC INDUSTRIES, INC.
K861218	AQUA ARK, IMMERSION HYDROBATH	Apr 18, 1986	Substantially Equivalent	AQUA ARK, INC.
K854861	SETMA HYGIA BATH MODEL ST 7200	Jan 03, 1986	Substantially Equivalent	SETMA, INC.
K854263	SETMA FHT, MODEL ST 8130	Nov 13, 1985	Substantially Equivalent	SETMA, INC.
K853163	SETMA VHT	Nov 05, 1985	Substantially Equivalent	SETMA, INC.
K844064	MEDO BUBBLE BATH MA-80, 400, 600 & 700	Jan 23, 1985	Substantially Equivalent	MEDO U.S.A., INC.
K842941	MULTIPLE PLANETAMED;PLANETA HYDROMASS	Aug 03, 1984	Substantially Equivalent	PLANETA HAUSGERAETE KG
K842643	MASSAPED	Jul 25, 1984	Substantially Equivalent	HEDDERNHEIMER METALLWARENFABRIK GMBH
K842642	BALSAN 700	Jul 25, 1984	Substantially Equivalent	HEDDERNHEIMER METALLWARENFABRIK GMBH
K842641	HYDRO/BUBBLE BATH DEVICE 300	Jul 25, 1984	Substantially Equivalent	HEDDERNHEIMER METALLWARENFABRIK GMBH
K841954	OASIS CLUB HYDROMASSAGE	May 23, 1984	Substantially Equivalent	PREXCOR AMERICA, INC.
K841397	BURN BATH	May 18, 1984	Substantially Equivalent	SETMA, INC.
K840282	OVERHEAD WHIRLPOOL HAND SPA BRAND	Feb 04, 1984	Substantially Equivalent	PRIEST ENTERPRISES, INC.
K833839	BIOTHERM	Dec 27, 1983	Substantially Equivalent	TRILEEN, INC.
K821809	THERMOFONTE AIR MESSAGE BATH	Jul 23, 1982	Substantially Equivalent	GREENFIELDS
K812033	THE LYMAN BATHCHAIR	Aug 13, 1981	Substantially Equivalent	THE LYMAN BATHCHAIR CORP.
K811904	CENTURY HYDRO-SAN THERAPY TANK	Jul 20, 1981	Substantially Equivalent	CENTURY MANUFACTURING CO.
K811903	CENTURY HYDROTHERAPY PUMP	Jul 20, 1981	Substantially Equivalent	CENTURY MANUFACTURING CO.
K810034	FOOT BATHS & HAND MASSAGERS	Jan 15, 1981	Substantially Equivalent	ASSOCIATED MILLS, INC.
K802335	WHIRLPOOL BATHING UNIT-#2001	Oct 10, 1980	Substantially Equivalent	AQUA CARE CORP.
K792641	HYDRO PULSE MASSAGE	Jan 28, 1980	Substantially Equivalent	HYDRO-PULSE RESEARCH, INC.
K791718	SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL	Oct 04, 1979	Substantially Equivalent	UNIVERSAL-KUNDLE CORP.
K791603	GILLETTE CORDLESS WHIRLPOOL	Sep 07, 1979	Substantially Equivalent	THE GILLETTE COMPANY
K771970	WHIRLPOOL BATH MODEL 50	Nov 02, 1977	Substantially Equivalent	DAZEY PRODUCTS CO.
K771969	TURBO-JET MODEL 76	Nov 02, 1977	Substantially Equivalent	DAZEY PRODUCTS CO.
K771966	VIBRO BATH MODEL FS-1	Nov 02, 1977	Substantially Equivalent	DAZEY PRODUCTS CO.
K771968	WHIRLPOOL BATH MODEL 2273	Oct 28, 1977	Substantially Equivalent	DAZEY PRODUCTS CO.
K771967	WHIRLPOOL BATH MODEL 2270	Oct 28, 1977	Substantially Equivalent	DAZEY PRODUCTS CO.
K771965	WHIRLPOOL BATH MODEL 2274	Oct 28, 1977	Substantially Equivalent	DOZEY PRODUCTS CO.
K771971	HYDROMASSAGE EQUIP. MODEL 1000	Oct 21, 1977	Substantially Equivalent	DAZEY PRODUCTS CO.

FEI Numbers

This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

1000136393: 5 registrations

1922538: 1 registration

2182947: 1 registration

3007420694: 35 registrations

3010010434: 4 registrations

3015139841: 11 registrations

3015335961: 6 registrations

3016446653: 10 registrations

3026182452: 6 registrations

3027500117: 1 registration

3035382597: 10 registrations