Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- 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
- 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
- K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)2Cleared 510(K)
- K243366DRX9000C-SL Cervical Spinal Decompression System2Cleared 510(K)
- K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac2Cleared 510(K)
- K222912c1Trac2Cleared 510(K)
- K151640ELTRAC 4712Cleared 510(K)
- K150695Modpod2Cleared 510(K)
- K131983ITRAC CERVICAL TRACTION SYSTEM2Cleared 510(K)
- K130249INTEGRITY SPINAL CARE SYSTEM 3.02Cleared 510(K)
- K112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-8002Cleared 510(K)
- K103248INTEGRITY SPINAL CARE SYSTEM2Cleared 510(K)
- K101889DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE2Cleared 510(K)
- K091540MTD 40002Cleared 510(K)
- K081247TM-4002Cleared 510(K)
- K072064GRAVILAX TRACTION SYSTEM2Cleared 510(K)
- K073132MODEL D DISC FORCE2Cleared 510(K)
- K073542CYCLETRAC CT-50002Cleared 510(K)
- K071347VAX-D GENESIS G2 SYSTEM2Cleared 510(K)
- K063353CTBOX CERVICAL/LUMBAR TRACTION2Cleared 510(K)
- K060735DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM2Cleared 510(K)
- K053223TRITON/TRU-TRAC/TX/TRITON DTS TRACTION2Cleared 510(K)
- K052453TRACTION SYSTEM, DIGIT-TRAC 9302Cleared 510(K)
- K053503VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)2Cleared 510(K)
- K051938TRITON/TRU-TRAC/TX TRACTION DEVICES2Cleared 510(K)
- K033231SPINA SYSTEM2Cleared 510(K)
- K051013SPINEMED S200B/S200C2Cleared 510(K)
- K042482BASS ANTALGIC-TRAK2Cleared 510(K)
- K043239HEALTHSTAR ELITE2Cleared 510(K)
- K031996EXTENTRAC ELITE2Cleared 510(K)
- K031862SPINERX-LDM2Cleared 510(K)
- K031227LORDEX POWER TRACTION EQUIPMENT2Cleared 510(K)
- K030060SPINEMED2Cleared 510(K)
- K022602DRX30002Cleared 510(K)
- K023160DRX50002Cleared 510(K)
- K010292DRX 20002Cleared 510(K)
- K0017123D ACTIVETRAC2Cleared 510(K)
- K002260SPINA SYSTEM2Cleared 510(K)
- K001361JILCO TRACTION-FLEXION CHAIR2Cleared 510(K)
- K001296SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM2Cleared 510(K)
- K001401AMT THERAPEUTIC TABLE, MODEL 748AMT2Cleared 510(K)
- K993919DYNATRON 9002Cleared 510(K)
- K991835HANG UPS POWER II2Cleared 510(K)
- K992733AKRON ATP9 TRACTION MACHINE2Cleared 510(K)
- K992545TM-300 TRACTION SYSTEM2Cleared 510(K)
- K991931CTD MARK I TRACTION DEVICE2Cleared 510(K)
- K981822DRS SYSTEM2Cleared 510(K)
- K951622VAX-D THERAPEUTIC TABLE2Cleared 510(K)
- K944699ATT-3002Cleared 510(K)
- K951228ASH-70002Cleared 510(K)
- K940200EXCEL TX2Cleared 510(K)
- K940590MINTO SKIN TRACTION MOTOR2Cleared 510(K)
- K930691ACCUTRAC TRACTION UNIT2Cleared 510(K)
- K923103JT-1 POWERED TRACTION UNIT2Cleared 510(K)
- K900575ULTRA-TRAC2Cleared 510(K)
- K900475DISTRAC(TM) TABLE2Cleared 510(K)
- K894435VAX-T PELVIC TRACTION BELT2Cleared 510(K)
- K893448TRU TRAC TRACTION TABLE2Cleared 510(K)
- K893168SPINALATOR JS-1100 TRACTION UNIT2Cleared 510(K)
- K881603ULTRA TRACTION2Cleared 510(K)
- K872780GUS TRAC C-3032Cleared 510(K)
- K862846TEC VARI-TRAC II TRACTION UNIT2Cleared 510(K)
- K862579TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-90002Cleared 510(K)
- K861832RICH-MAR SPINA-MOBILIZOR2Cleared 510(K)
- K860227POWERED TRACTION EQUIPMENT2Cleared 510(K)
- K844385ESCOTEK EST TRAC 4012Cleared 510(K)
- K843522DONWAY SPLINT2Cleared 510(K)
- K843581PROM NAID2Cleared 510(K)
- K834405TEC TRACTION MACHINE2Cleared 510(K)
- K830088TRACTION 2302Cleared 510(K)
- K821002INVERCHAIR2Cleared 510(K)
- K772154CERVICAL TRACTION DIV., PNEUMATIC2Cleared 510(K)
- K770610TABLE, TREATMENT & TRACTION, HI-LO2Cleared 510(K)
- 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
DONWAY SPLINT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K843522
- 510(k) Type
- Traditional
- Applicant
- AUSTRALIAN BIOMEDICAL CORPORATION LTD.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/7/1985
- Days to Decision
- 153 days