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
- IKDCable, Electrode2Product Code
- IKETransducer, Miniature Pressure1Product Code
- IKKSystem, Isokinetic Testing And Evaluation2Product Code
- K123746AMES THERAPY DEVICE2Cleared 510(K)
- K952090HUMAC SYSTEM2Cleared 510(K)
- K951770BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP2Cleared 510(K)
- K951916CC RIDER, MODEL ME1802Cleared 510(K)
- K950095CYBEX 7702Cleared 510(K)
- K942229MOTIVATOR FTR 20002Cleared 510(K)
- K944732DEXTER ISOKINETIC2Cleared 510(K)
- K924414THE BTE DYNAMIC LIFT2Cleared 510(K)
- K923350CLOSED CHAIN ATTACHMENT, MODEL #820-5202Cleared 510(K)
- K922772TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR2Cleared 510(K)
- K922092SINGLE CHAIR INTEGRAL BACK ATTACHMENT2Cleared 510(K)
- K915144DEXTER HAND EVALUATION AND THERAPY SYSTEM2Cleared 510(K)
- K915846BIODEX SYSTEM 2 AUTOPROGRAM2Cleared 510(K)
- K915648BIODEX SYSTEM 2 AUTOPROGRAM2Cleared 510(K)
- K913021BIODEX,MODEL B-20002Cleared 510(K)
- K913020BIODEX SYSTEM 2,MODEL S2-S2Cleared 510(K)
- K911805KIN-COM ASYMMETRICAL BACK SYSTEM2Cleared 510(K)
- K911666MEDX MACHINE2Cleared 510(K)
- K905525CYBEX 60002Cleared 510(K)
- K904898TORQUE FRAME QTF10002Cleared 510(K)
- K901566PROMATRON 30002Cleared 510(K)
- K903429LIDO LINEA2Cleared 510(K)
- K902219KRONAMAX HUMAN PERFORMANCE LAB2Cleared 510(K)
- K900450BIODEX LIFT SIMULATOR2Cleared 510(K)
- K881681CYBEX BACK TESTING AND REHABILITATION SYSTEM2Cleared 510(K)
- K881676LINEAR LIFT DEVICE2Cleared 510(K)
- K900741BIODEX BACK SYSTEM ATTACHMENT2Cleared 510(K)
- K896553MEDX CERVICAL EXTENSION TEST & REHAB MACHINE2Cleared 510(K)
- K894662TEST ONE2Cleared 510(K)
- K895398BIO-COORDINATOR SYSTEM2Cleared 510(K)
- K895236MEDX REHABILITATION MACHINE2Cleared 510(K)
- K884487LIDO TM ACTIVE BACK2Cleared 510(K)
- K873659MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO2Cleared 510(K)
- K880230SIXALYZER2Cleared 510(K)
- K880018LIDO(TM) WORKSET2Cleared 510(K)
- K880017LIDO(TM) LIFT2Cleared 510(K)
- K875235ISOKINETIC SYSTEM, TESTING AND EVALUATION2Cleared 510(K)
- K872911CYBEX 3402Cleared 510(K)
- K871557DISCIPLINE II RTD2Cleared 510(K)
- K872199DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER2Cleared 510(K)
- K871793LIDO ACTIVE2Cleared 510(K)
- K863313GRIP STRENGTH DEVICE (GSD)2Cleared 510(K)
- K862996PORTABLE ISOKINETICS 3004 KNEE UNIT2Cleared 510(K)
- K862998PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT2Cleared 510(K)
- K862997PORTABLE ISOKINETICS 3005 HIP UNIT2Cleared 510(K)
- K862993PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT2Cleared 510(K)
- K862995PORTABLE ISOKINETICS 3003 SHOULDER UNIT2Cleared 510(K)
- K862994PORTABLE ISOKINETICS 3002 ISO KANE II2Cleared 510(K)
- K862780TRU-KINETICS (TM)2Cleared 510(K)
- K862096STATIC STRENGTH TESTER2Cleared 510(K)
- K861986LIDO BACK2Cleared 510(K)
- K861632SIMS CHAIR2Cleared 510(K)
- K861622SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER2Cleared 510(K)
- K861206NAUTILUS LEG EXTENSION TESTING & REHABILITATION2Cleared 510(K)
- K860821BIODEX SYSTEM2Cleared 510(K)
- K844368LINEAR LIFT DEVICE2Cleared 510(K)
- K843739CYBEX TORSO TESTING & REHABILITATION2Cleared 510(K)
- K844060ISOSTATION ANKLE/SUBTALAR MACHINE A-1002Cleared 510(K)
- K842296ISOSTATION LOWER BACK MACHINE2Cleared 510(K)
- K841849ISOSTATION SHOULDER MACHINE2Cleared 510(K)
- K832770LANE ONE2Cleared 510(K)
- IKOHammer, Reflex, Powered2Product Code
- IKPChronaximeter2Product Code
- ISBStimulator, Muscle, Diagnostic2Product Code
- JFCSystem, Pressure Measurement, Intermittent1Product Code
- KHXPlatform, Force-Measuring1Product Code
- OALExercise Equipment, Powered, Emg-Triggered2Product Code
- 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
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BIO-COORDINATOR SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K895398
- 510(k) Type
- Traditional
- Applicant
- BIO-HARMONIZER, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/28/1989
- Days to Decision
- 21 days