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
- 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
- K143414Hill-Rom Wireless Connectivity Module2Cleared 510(K)
- K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO22Cleared 510(K)
- K973624NURSE'S AID PATIENT ROTATION SYSTEM2Cleared 510(K)
- K970363HYDROTEC LOW AIR LOSS THERAPY BED2Cleared 510(K)
- K970364AIRTEC2 LOW AIR LOSS THERAPY BED2Cleared 510(K)
- K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)2Cleared 510(K)
- K964873SILKAIR LOW AIRLOSS THERAPY2Cleared 510(K)
- K970295FLEXICAIR EXLIPSE PLUS2Cleared 510(K)
- K943433TOTAL CONTACT SEAT RIPPLE SYSTEM2Cleared 510(K)
- K951001FLEXICAIR EXLIPSE2Cleared 510(K)
- K945729DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE2Cleared 510(K)
- K941610CLENSICAIR LOW AIRLOSS HYDROTHERAPY2Cleared 510(K)
- K940662I-50002Cleared 510(K)
- K931594THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM2Cleared 510(K)
- K932480PRISM2Cleared 510(K)
- K926189ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE2Cleared 510(K)
- K926456MICROAIR TURN-Q2Cleared 510(K)
- K925694MICROAIR PUP2Cleared 510(K)
- K923977AKROTECH 40002Cleared 510(K)
- K922973RESTCUE CC2Cleared 510(K)
- K922140ORTHODERM CONVERTIBLE II2Cleared 510(K)
- K921768HAZEL II2Cleared 510(K)
- K920382FLEXICAIR LOW AIRLOSS THERAPY UNIT2Cleared 510(K)
- K915671B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT2Cleared 510(K)
- K912854TURBO2Cleared 510(K)
- K914674MICROAIR 35002Cleared 510(K)
- K914851CLA-1400 SYSTEM2Cleared 510(K)
- K912855HAZEL2Cleared 510(K)
- K910851TASSI MK3 (TURNAIR)2Cleared 510(K)
- K905126COMFORT-AIRE2Cleared 510(K)
- K905156BIO MEDX AIR FLOTATION SYSTEM2Cleared 510(K)
- K905053STAGE ZERO AIR FLOTATION BED2Cleared 510(K)
- K903659STAGE III2Cleared 510(K)
- K901890MARK IV FLOATATION THERAPY BED2Cleared 510(K)
- K901295PULMONAIR 40 PATIENT MANAGEMENT SYSTEM2Cleared 510(K)
- K894723SYSTEM 2500 MEDICAL WATERBED2Cleared 510(K)
- K894353ORTHODERM CONVERTIBLE2Cleared 510(K)
- K893801M.F.S. LOW AIR LOSS PULSATING BED2Cleared 510(K)
- K893708FLUIDIZED AIR BED2Cleared 510(K)
- K893614AEROMAT MRS-10002Cleared 510(K)
- K890935SYSTEM 3000 FLUIDIZED AIR BED2Cleared 510(K)
- K882177ADD-ON TO CRITICAL PATIENT CARE BED2Cleared 510(K)
- K883192SMI 3000 AIRBED2Cleared 510(K)
- K881843PEDIATRIC HOSPITAL BED2Cleared 510(K)
- K882607ULTRAFLOTATION BED2Cleared 510(K)
- K882229AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS2Cleared 510(K)
- K880486DERMGARD SYSTEM 800 AND 9002Cleared 510(K)
- K875321MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE2Cleared 510(K)
- K871614DECUB-I-CON 800 AND 900 SYSTEM2Cleared 510(K)
- K871368SCHELL C.A.P.P. BED MODEL NRS. 1268 + 12692Cleared 510(K)
- K864232ROTATION AIR FLUIDIZED BED/DELTA2Cleared 510(K)
- K863047FLEXICAIR2Cleared 510(K)
- K840882HOME CARE WATER FLOTATION BED HC4/TC/H2Cleared 510(K)
- K840881WATER FLOATION BED 800/TC/H2Cleared 510(K)
- K840697CALM WATER FLOTATION HOSPITAL BED2Cleared 510(K)
- K832829NEO-FLOAT NEONATAL FLOTATION SYS & RHYT2Cleared 510(K)
- K771264FLOTATION THERAPY BED2Cleared 510(K)
- 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
HAZEL II
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K921768
- 510(k) Type
- Traditional
- Applicant
- KINETIC CONCEPTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/29/1992
- Days to Decision
- 15 days
- Submission Type
- Statement