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
- 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
- K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra2Cleared 510(K)
- K183296REAL Immersive System2Cleared 510(K)
- K143512ActiSpec Activity Monitor2Cleared 510(K)
- K112121ERGOSELECT/GE2Cleared 510(K)
- K080545ACTITRAINER2Cleared 510(K)
- K053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/P2Cleared 510(K)
- K990866QUINTON MEDTRACK CR PLUS TREADMILL2Cleared 510(K)
- K990813REHCOR2Cleared 510(K)
- K962855ULE-2, MULE-2, HAND ACCESSORY KIT2Cleared 510(K)
- K952163DAVID BACK CLINIC SYSTEM2Cleared 510(K)
- K941033PHYSIO HAB2Cleared 510(K)
- K940065SES1002Cleared 510(K)
- K934238MULE2Cleared 510(K)
- K930735LORDEX LUMBAR EXTENSION MACHINE2Cleared 510(K)
- K933611THE BTE WS302Cleared 510(K)
- K926278STAIR CLIMBER2Cleared 510(K)
- K926279UPPER BODY EXERCISER2Cleared 510(K)
- K926287EXERCISE BICYCLE2Cleared 510(K)
- K926314HYDRA FITNESS MODEL 311 TOTAL POWER2Cleared 510(K)
- K930253CARDIO2 CTCKE2Cleared 510(K)
- K926170STEPMILL EXERCISE SYSTEM2Cleared 510(K)
- K922603TOTAL WORK INTEGRATOR, MODEL #940-1102Cleared 510(K)
- K922606MULTI JOINT WEIGHT SYSTEM MODEL #940-1002Cleared 510(K)
- K922602CABLE COLUMN WEIGHT SYSTEM MODEL #940-2002Cleared 510(K)
- K912140STAIRMASTER MODEL 6000 ERGOMETER2Cleared 510(K)
- K912056GRAVITRON UPPER BODY SYSTEM EXERCISER2Cleared 510(K)
- K9120574000 PT EXERCISE SYSTEM2Cleared 510(K)
- K912058GAUNTLET STAIR CLIMBER2Cleared 510(K)
- K912227MONARK ERGOMETERS2Cleared 510(K)
- K904823FLEXERCYCLE2Cleared 510(K)
- K894154METABOLIC SYSTEMS2Cleared 510(K)
- K890401GOLDEN MEAN MACHINE(TM) (CLASS 2)2Cleared 510(K)
- K880032MEDEX MACHINE2Cleared 510(K)
- K880271RESUBMITTED EXCALIBUR2Cleared 510(K)
- K871494UPPERCYCLE STATIONARY EXERCISE MACHINES2Cleared 510(K)
- K870872DISCIPLINE I2Cleared 510(K)
- K864581APPLIDYN2Cleared 510(K)
- K863884PULSESTAR EXERCISE BIKE2Cleared 510(K)
- K861348R1361 & R1372 MEASURED EXERCISE EQUIPMENT2Cleared 510(K)
- K851967TORQUE FEEDBACK METER2Cleared 510(K)
- K851946REMOTE SPEED CONTROL2Cleared 510(K)
- K851097LODE MODEL CORIVAL ERGOMETER2Cleared 510(K)
- K850869MFE COUCH ERGOMETER2Cleared 510(K)
- K843850UNIVERSAL-ERGOTEST2Cleared 510(K)
- K8343603-D PASSIVE MOBILIZER2Cleared 510(K)
- K834098STATIONARY EXERCISE BICYCLE2Cleared 510(K)
- K832940ROTAGYM2Cleared 510(K)
- K801868CAL-COUNT2Cleared 510(K)
- K800939COMPUTRIM 9002Cleared 510(K)
- K800892NUCLEAR STRESS TABLE (NST-1)2Cleared 510(K)
- K800072DIGITAL ELECTRONIC EXERCISER/PULSE MTR.2Cleared 510(K)
- K792591STRESS TABLE/ERGOMETER SYSTEM2Cleared 510(K)
- K792120AEROBITRON II2Cleared 510(K)
- K792121AEROBITRON III2Cleared 510(K)
- K791966AEROBITRON 12Cleared 510(K)
- K791866STANDARD HEALTH BIKE MODEL 0192Cleared 510(K)
- K781997AUTORANGE2Cleared 510(K)
- K781889COLLINS PEDALMATE 22Cleared 510(K)
- K770234MODEL 880 REHABILITATION TRAINER2Cleared 510(K)
- K770148CALIBRATED GRASPING TUBES2Cleared 510(K)
- K770164FINGER MUSCLE TESTER2Cleared 510(K)
- 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
ROTAGYM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K832940
- 510(k) Type
- Traditional
- Applicant
- I-REP, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/7/1983
- Days to Decision
- 70 days