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
- K240788Ultrasound Stimulator2Cleared 510(K)
- K230472Sonopuls 1902Cleared 510(K)
- K222098ManaSport+2Cleared 510(K)
- K210284ManaSport2Cleared 510(K)
- K202788Sonomed IV, Sonomed V2Cleared 510(K)
- K160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)2Cleared 510(K)
- K161628JAS Pulse(TM) Ultrasonic Therapy2Cleared 510(K)
- K160075Accent XL2Cleared 510(K)
- K161502MC1 Plus2Cleared 510(K)
- K142976UltraTENS2Cleared 510(K)
- K131309SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ2Cleared 510(K)
- K130888SONOPULSE/ SONOPULSE III2Cleared 510(K)
- K124010ACCUSONIC ADVANTAGE2Cleared 510(K)
- K120171ACCUSONIC ADVANTAGE2Cleared 510(K)
- K112520US-101L, US-103S2Cleared 510(K)
- K091615MED CONTOUR2Cleared 510(K)
- K090542SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-9002Cleared 510(K)
- K062256HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM2Cleared 510(K)
- K053041MED SCULPT2Cleared 510(K)
- K052934DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM2Cleared 510(K)
- K053546SONICATOR 740, MODEL ME 7402Cleared 510(K)
- K050410HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)2Cleared 510(K)
- K040798HES ULTRASONIC THERAPY APPLIANCE2Cleared 510(K)
- K031116VECTRA (INTELECT) EPR ULTRASOUND2Cleared 510(K)
- K024013SUN-RAIN ULTRASONIC THERAPY, SU-1002Cleared 510(K)
- K031329DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)2Cleared 510(K)
- K032793US-100 PORTABLE ULTRASOUND THERAPY UNIT2Cleared 510(K)
- K024307DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM2Cleared 510(K)
- K030878ACCOUSONIC, MODEL AS-2702Cleared 510(K)
- K030410ACCOUSONIC PLUS, MODEL AP-1702Cleared 510(K)
- K021483RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND2Cleared 510(K)
- K013192SONICATOR PLUS 930, MODEL ME 9302Cleared 510(K)
- K010702XUB EXTERNAL ULTRASOUND2Cleared 510(K)
- K011955MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-1002Cleared 510(K)
- K010609ACCUSONIC, MODEL AS-2602Cleared 510(K)
- K010102SONIC MODEL SO-3002Cleared 510(K)
- K991613SW ULTRASOUND, MODELS 331, 311, 3332Cleared 510(K)
- K000593SONIC, MODEL SO-1002Cleared 510(K)
- K000084ENRAF-NONIUS SONOPULS 190 SYSTEM2Cleared 510(K)
- K001370ACCUSONIC PLUS, MODEL AP-1002Cleared 510(K)
- K000604NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT2Cleared 510(K)
- K984199EXONIX2Cleared 510(K)
- K981449SD-956 ULTRASOUND THERAPY2Cleared 510(K)
- K982544RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES2Cleared 510(K)
- K982829FORTE, MODEL CPS ULTRASOUND2Cleared 510(K)
- K973024INTELECT LEGEND ULTRASOUND2Cleared 510(K)
- K970131ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE2Cleared 510(K)
- K961250DYNATRON 125 ULTRASOUND2Cleared 510(K)
- K960802CUSHMAN MANUFACTURING, INC. ULTRA 6.0.2Cleared 510(K)
- K954136MATRIX MICROSON 4102Cleared 510(K)
- K952536SONO 52Cleared 510(K)
- K944596GRAHAM-FIELD ULTRASOUND LOTION2Cleared 510(K)
- K950564RICH-MAR US-II ULTRASOUND2Cleared 510(K)
- K930307INTELECT 222 P2Cleared 510(K)
- K930186INTERTRON 6000/61002Cleared 510(K)
- K922839MID-CANADA MEDICAL2Cleared 510(K)
- K923076ULTRA SX2Cleared 510(K)
- K920983SONOPULS 5902Cleared 510(K)
- K915557RICH-MAR MODEL 510 ULTRASOUND2Cleared 510(K)
- K913981RICH-MAR MODEL II ULTRASOUND2Cleared 510(K)
- K912202RICH-MAR MODEL 25 ULTRASOUND2Cleared 510(K)
- K910708RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE2Cleared 510(K)
- K904051RICH-MAR MODEL V ULTRASOUND2Cleared 510(K)
- K901950DITER ULTRASONIC S 30002Cleared 510(K)
- K894152MEDITHERM2Cleared 510(K)
- K883228SONICATOR 720 (MODEL ME720)2Cleared 510(K)
- K881211TRU-TECH 310 ULTRASOUND THERAPY UNIT #3102Cleared 510(K)
- K875381ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER2Cleared 510(K)
- K880901SONICATOR 710 (MODEL ME710)2Cleared 510(K)
- K880602MODIFIED SONICATOR 720, MODEL ME7202Cleared 510(K)
- K873812SONICATOR 720 (MODEL ME720)2Cleared 510(K)
- K872393SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT2Cleared 510(K)
- K860099MEDCO-SONIC NQ-20002Cleared 510(K)
- K851937SONOMED 42Cleared 510(K)
- K851397SONICATOR 705 MODEL ME 7052Cleared 510(K)
- K850640SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT2Cleared 510(K)
- K844386ESCOTEK-EST 301A ULTRA-SONIC UNIT2Cleared 510(K)
- K844036US 6102Cleared 510(K)
- K843372OMNISOUND THERAPY UNIT2Cleared 510(K)
- K843221MEGASON MODEL 1502Cleared 510(K)
- K841447INTELECT 210 PORTABLE ULTRASOUND2Cleared 510(K)
- K841445INTELECT 205 PORTABLE ULTRASOUND UNIT2Cleared 510(K)
- K841446INTELECT 200 THERAPEUTIC ULTRASOUND2Cleared 510(K)
- K813593INTELECT MODEL 2002Cleared 510(K)
- K812752MICRO MED INT'L MICRO SOUND US-1002Cleared 510(K)
- K811159DYNASOUND 8012Cleared 510(K)
- K800632MODEL 118 PULSE MEGASON2Cleared 510(K)
- K791976DYNASOUND 6012Cleared 510(K)
- K781317ULTRASONIC THERAPY APPARATUS, 4072Cleared 510(K)
- 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
- 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
EXONIX
- Page Type
- Cleared 510(K)
- 510(k) Number
- K984199
- 510(k) Type
- Traditional
- Applicant
- FIBRA SONICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/17/1999
- Days to Decision
- 85 days
- Submission Type
- Statement