Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- MOCCushion, Flotation, Therapeutic2Product Code
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat2Product Code
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat2Product Code
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat2Product Code
- QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser2Product Code
- QRAVirtual Reality Behavioral Therapy Device For Pain Relief2Product Code
- BXBExerciser, Powered1Product Code
- EGJDevice, Iontophoresis, Other Uses2Product Code
- HPHDiathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- IKWUtensil, Homemaking1Product Code
- IKXAid, Transfer1Product Code
- IKZBed, Patient Rotation, Powered2Product Code
- ILCUtensil, Eating1Product Code
- ILDAdaptor, Dressing1Product Code
- ILJBath, Hydro-Massage2Product Code
- K110994PARKER 5002Cleared 510(K)
- K082951IMMERSION HYDROBATH2Cleared 510(K)
- K052479MBATH 1000 (60)2Cleared 510(K)
- K040772PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM2Cleared 510(K)
- K012061SUPERIOR BATH, MODEL 63002Cleared 510(K)
- K012057CASCADE BATH, MODEL 69002Cleared 510(K)
- K001079RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO2Cleared 510(K)
- K993872VANNA BATHING SYSTEM2Cleared 510(K)
- K992779A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM2Cleared 510(K)
- K991184HYDROTONE-THERMAL CAPSULE SYSTEM2Cleared 510(K)
- K980909VICHY SHOWER2Cleared 510(K)
- K980920EQUINOXE2Cleared 510(K)
- K974321HYDROTONE2Cleared 510(K)
- K980033FERNO HEALTHCARE RECLINE-A-BATH 22Cleared 510(K)
- K980769WINDMERE MODEL DS-2 FOOT BATH2Cleared 510(K)
- K971592XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM2Cleared 510(K)
- K971593SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT2Cleared 510(K)
- K964926BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC2Cleared 510(K)
- K952442FREEDOM BATH2Cleared 510(K)
- K930665CENTURY BATHING SYSTEM2Cleared 510(K)
- K930821THERA-FIT2Cleared 510(K)
- K930820AQUADYNE2Cleared 510(K)
- K925195MALIBU BATHING SYSTEM2Cleared 510(K)
- K925193AQUACISER II2Cleared 510(K)
- K930624SANITAS WHIRPOOL BATHING SYSTEM2Cleared 510(K)
- K930096NO CROSS CONTAM HYDROTHERAPY TANK LINER2Cleared 510(K)
- K923637ARJO-CENTURY ARM AND LEG TANK SYSTEM2Cleared 510(K)
- K923617FULL MOVEMENT THERAPY SYSTEMS2Cleared 510(K)
- K923159ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS2Cleared 510(K)
- K922160AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS2Cleared 510(K)
- K914125FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 4032Cleared 510(K)
- K911758AMISH COUNTRY SPA2Cleared 510(K)
- K911551SHOWER MINI RD-7 SANITARY WASHER2Cleared 510(K)
- K905599JETTA JR. HYDRO MASSAGE2Cleared 510(K)
- K910607PACIFIC MARQUIS SPA2Cleared 510(K)
- K904106SPA SHELL2Cleared 510(K)
- K902603LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH2Cleared 510(K)
- K890548AQUACISER SYSTEM2Cleared 510(K)
- K890308HYDROTONE I2Cleared 510(K)
- K883187SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM2Cleared 510(K)
- K883308PARKER BATHING SYSTEM2Cleared 510(K)
- K880355MODEL 938 BATHING SYSTEM2Cleared 510(K)
- K872327WHIRLPOOL AERATOR WB700, WB800, WB900, WB9752Cleared 510(K)
- K864721CRYOTHERM2Cleared 510(K)
- K861218AQUA ARK, IMMERSION HYDROBATH2Cleared 510(K)
- K854861SETMA HYGIA BATH MODEL ST 72002Cleared 510(K)
- K854263SETMA FHT, MODEL ST 81302Cleared 510(K)
- K853163SETMA VHT2Cleared 510(K)
- K844064MEDO BUBBLE BATH MA-80, 400, 600 & 7002Cleared 510(K)
- K842941MULTIPLE PLANETAMED;PLANETA HYDROMASS2Cleared 510(K)
- K842642BALSAN 7002Cleared 510(K)
- K842641HYDRO/BUBBLE BATH DEVICE 3002Cleared 510(K)
- K842643MASSAPED2Cleared 510(K)
- K841954OASIS CLUB HYDROMASSAGE2Cleared 510(K)
- K841397BURN BATH2Cleared 510(K)
- K840282OVERHEAD WHIRLPOOL HAND SPA BRAND2Cleared 510(K)
- K833839BIOTHERM2Cleared 510(K)
- K821809THERMOFONTE AIR MESSAGE BATH2Cleared 510(K)
- K812033THE LYMAN BATHCHAIR2Cleared 510(K)
- K811904CENTURY HYDRO-SAN THERAPY TANK2Cleared 510(K)
- K811903CENTURY HYDROTHERAPY PUMP2Cleared 510(K)
- K810034FOOT BATHS & HAND MASSAGERS2Cleared 510(K)
- K802335WHIRLPOOL BATHING UNIT-#20012Cleared 510(K)
- K792641HYDRO PULSE MASSAGE2Cleared 510(K)
- K791718SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL2Cleared 510(K)
- K791603GILLETTE CORDLESS WHIRLPOOL2Cleared 510(K)
- K771970WHIRLPOOL BATH MODEL 502Cleared 510(K)
- K771966VIBRO BATH MODEL FS-12Cleared 510(K)
- K771969TURBO-JET MODEL 762Cleared 510(K)
- K771967WHIRLPOOL BATH MODEL 22702Cleared 510(K)
- K771968WHIRLPOOL BATH MODEL 22732Cleared 510(K)
- K771965WHIRLPOOL BATH MODEL 22742Cleared 510(K)
- K771971HYDROMASSAGE EQUIP. MODEL 10002Cleared 510(K)
- ILKTransport, Patient, Powered2Product Code
- ILMBath, Sitz, Powered2Product Code
- ILOPack, Hot Or Cold, Water Circulating2Product Code
- ILSAdaptor, Hygiene1Product Code
- ILTAdaptor, Recreational1Product Code
- ILWAdaptor, Grooming1Product Code
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat2Product Code
- ILYLamp, Infrared, Therapeutic Heating2Product Code
- ILZAccessories, Traction1Product Code
- IMAPack, Heat, Moist1Product Code
- IMBCabinet, Moist Steam2Product Code
- IMCBath, Paraffin2Product Code
- IMDPack, Hot Or Cold, Disposable1Product Code
- IMEPack, Hot Or Cold, Reusable1Product Code
- IMFUnit, Chilling1Product Code
- INXBed, Air Fluidized2Product Code
- INYBed, Patient Rotation, Manual1Product Code
- IOADiathermy, Microwave, For Use In Applying Therapeutic Deep Heat2Product Code
- IOBLamp, Infrared, Non Heating2Product Code
- IODComponents, Exercise1Product Code
- IOEBars, Parallel, Exercise1Product Code
- IOGTreadmill, Mechanical1Product Code
- IOLTreadmill, Powered1Product Code
- IONExerciser, Non-Measuring1Product Code
- IOQBed, Flotation Therapy, Powered2Product Code
- IPFStimulator, Muscle, Powered2Product Code
- IRNDevice, Warning, Overload, External Limb, Powered2Product Code
- IROVibrator, Therapeutic1Product Code
- IRPMassager, Powered Inflatable Tube2Product Code
- IRQUnit, Heating, Powered1Product Code
- IRRBars, Parallel, Powered1Product Code
- IRSHead Halter, Traction1Product Code
- IRTPad, Heating, Powered2Product Code
- ISAMassager, Therapeutic, Electric1Product Code
- ISDExerciser, Measuring2Product Code
- ITHEquipment, Traction, Powered2Product Code
- JFAExerciser, Finger, Powered1Product Code
- JFBTable, Physical Therapy, Multi Function2Product Code
- KNLBoard, Scooter, Prone1Product Code
- KNMDevice, Pressure Applying1Product Code
- KTBDevice, Iontophoresis, Specific Uses2Product Code
- KTCBath, Sitz, Nonpowered1Product Code
- LBGDevice, Fluidized Therapy, Dry Heat2Product Code
- LSBUnit, Fluidotherapy2Product Code
- LXFDiathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- LXJInteractive Rehabilitation Exercise Devices2Product Code
- LYGMassager, Therapeutic, Manual1Product Code
- MPOInfant Heel Warmer (Chemical Heat Pack)1Product Code
- NGXStimulator, Muscle, Powered, For Muscle Conditioning2Product Code
- NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy2Product Code
- NYYStimulator, Muscle, Powered, With Limited Output, For Rehabilitation2Product Code
- NYZStimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning2Product Code
- OMWAdhesive Backed Thermal Skin Patches1Product Code
- OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature2Product Code
- PCDPowered Stairway Chair Lift2Product Code
- PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat2Product Code
- PHWCold Pack And Vibrating Massager1Product Code
- PKSExerciser, Non-Measuring For Stroke Rehabilitation1Product Code
- PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain2Product Code
- QKCInteractive Rehabilitation Exercise Device, Prescription Use2Product Code
- QKDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use2Product Code
- QTCAdult Portable Bed Rails For Medical Purposes1Product Code
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BIOTHERM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K833839
- 510(k) Type
- Traditional
- Applicant
- TRILEEN, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/27/1983
- Days to Decision
- 54 days