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
- K153559OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System2Cleared 510(K)
- K150436ComboRehab2Cleared 510(K)
- K150353BTL-40002Cleared 510(K)
- K120217SONICSTIMU COMBO THERAPEUTIC DEVICE2Cleared 510(K)
- K121059SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM2Cleared 510(K)
- K102524FUTURA2Cleared 510(K)
- K111482SONICATOR PLUS 9202Cleared 510(K)
- K102190WINSTIM2Cleared 510(K)
- K092627CT2011 SONICSTIMU PAIN RELIEF DEVICE2Cleared 510(K)
- K071137SONICATOR PLUS 940, MODEL ME9402Cleared 510(K)
- K063728TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM2Cleared 510(K)
- K063135SONIC-STIM2Cleared 510(K)
- K052340DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM2Cleared 510(K)
- K040285VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER2Cleared 510(K)
- K040121DERMAWAVE 5000 COMBI MAX SYSTEM2Cleared 510(K)
- K031077VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM2Cleared 510(K)
- K030880VECTORSONIC, MODEL VU-2702Cleared 510(K)
- K023050RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI2Cleared 510(K)
- K020119VECTORSONIC, MODEL VU-2002Cleared 510(K)
- K001166ULTRA V THERAPEUTIC ULTRASOUND2Cleared 510(K)
- K982317VECTRA COMBO2Cleared 510(K)
- K982830FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO2Cleared 510(K)
- K953614FORTE2Cleared 510(K)
- K951746FORTE CB2Cleared 510(K)
- K943469SONICATOR 7302Cleared 510(K)
- K941561FORTE US2Cleared 510(K)
- K935728DYNATRON 1502Cleared 510(K)
- K940180FORTE US2Cleared 510(K)
- K934287DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR2Cleared 510(K)
- K934846SONICATOR 7162Cleared 510(K)
- K935271THERAPEUTIC ULTRASOUND AND STIMULATOR2Cleared 510(K)
- K934845SONICATOR 7152Cleared 510(K)
- K932937DYNATRON 8002Cleared 510(K)
- K922036SONOPULS 5912Cleared 510(K)
- K921436SONICATOR PLUS2Cleared 510(K)
- K921952ULTRA III2Cleared 510(K)
- K920939DYNATRON 300 ULRASOUND2Cleared 510(K)
- K923797MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED2Cleared 510(K)
- K911733INTELECT, MODEL 2452Cleared 510(K)
- K902875INTELECT 750 MP2Cleared 510(K)
- K902860INTELECT 1702Cleared 510(K)
- K900189CURAPULS 403 DIATHERMY UNIT2Cleared 510(K)
- K895690ULTRA (THERAPEUTIC ULTRASOUND DEVICE)2Cleared 510(K)
- K883893OMNISOUND(TM) 30002Cleared 510(K)
- K872909SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION2Cleared 510(K)
- K872394SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT2Cleared 510(K)
- K871647STIMULATOR, ULTRASOUND AND MUSCLE2Cleared 510(K)
- K861837FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND2Cleared 510(K)
- K844217RICH-MAR DELTA 330 HV2Cleared 510(K)
- K843351OMNISTIM II COMBIN. THERAPY SYS2Cleared 510(K)
- K813594INTELECT MODEL 7002Cleared 510(K)
- K810526RICH-MAR HV II SELECT-A-PULSE2Cleared 510(K)
- K772287MUSCLE STIMULATOR2Cleared 510(K)
- K771157RM VI-HV2Cleared 510(K)
- 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
- 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
OMNISOUND(TM) 3000
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K883893
- 510(k) Type
- Traditional
- Applicant
- PHYSIO TECHNOLOGY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/1/1988
- Days to Decision
- 48 days