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
- K072887G-TRAINER MEDICAL1Cleared 510(K)
- K003272FLO-BOOT1Cleared 510(K)
- K952975ANKLE CALF EXERCISER PHLEBOPUMP1Cleared 510(K)
- K953456E-Z FLEX1Cleared 510(K)
- K955105BTE CPM-101Cleared 510(K)
- K955106BTE CPM-201Cleared 510(K)
- K951028HAMEX TWO1Cleared 510(K)
- K950755FLEXMATE K5001Cleared 510(K)
- K951029HAMEX ONE1Cleared 510(K)
- K945733AQUAHAB, MODEL 120-72-1011Cleared 510(K)
- K950682W2 WRIST CPM UNIT1Cleared 510(K)
- K952369KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE1Cleared 510(K)
- K945690BACKCYCLER CPM(TM)1Cleared 510(K)
- K946169ACTIC 20021Cleared 510(K)
- K945824GALAXY MD SERIES THERAPYPOOLS1Cleared 510(K)
- K944819KRDL 20001Cleared 510(K)
- K945221SUTTER MODEL 6000 HAND CPM DEVICE1Cleared 510(K)
- K945121A3 ANKLE CPM UNIT1Cleared 510(K)
- K940455LATERAL FLEXION MACHINE1Cleared 510(K)
- K935011SWIMEX MULTIDEPTH POOL (MODEL 600T)1Cleared 510(K)
- K935587MULTILINK SHOULDER CPM UNIT1Cleared 510(K)
- K941128OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS1Cleared 510(K)
- K935509HYDROTRACK1Cleared 510(K)
- K935520UPPER BODY CYCLES (110 VOLT)/(220 VOLT)1Cleared 510(K)
- K935216SEMI-RECUMBENT CYCLES1Cleared 510(K)
- K935061LOWER BODY CYCLES1Cleared 510(K)
- K942618ANKLE CALF EXERCISER1Cleared 510(K)
- K933059ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD.1Cleared 510(K)
- K926136WATSYSTEM1Cleared 510(K)
- K931128BASIC SHOULDER CPM1Cleared 510(K)
- K935467R & D BATTERIES, INC. PART NUMBER 54471Cleared 510(K)
- K935188STRETCHPOWER1Cleared 510(K)
- K934175STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER1Cleared 510(K)
- K935808REVOLUTION LOWER LIMB CPM UNIT1Cleared 510(K)
- K933394DANNIFLEX CPM 6001Cleared 510(K)
- K930780ADV400 TOE CPM1Cleared 510(K)
- K926313COMPUTERIZED TESTING AND EXERCISE SYSTEMS1Cleared 510(K)
- K931555ARTROMOT K2 CPM1Cleared 510(K)
- K931736M-FLEX 5000 C3PMD1Cleared 510(K)
- K933311MOTORIZED ELECTRIC PARALLEL BARS1Cleared 510(K)
- K931723HYDRO-TRED/AIR POWERED TREADMILL1Cleared 510(K)
- K926262FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE1Cleared 510(K)
- K925270EX N' FLEX EF-2001Cleared 510(K)
- K925977PARAMED FLEXION-EXTENSION MACHINE1Cleared 510(K)
- K925271REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE1Cleared 510(K)
- K924513LIDO(R) LINEA1Cleared 510(K)
- K925807AQUACISER IN-POOL TREADMILL1Cleared 510(K)
- K925926MOBILIMB T1 TOE CPM UNIT1Cleared 510(K)
- K924484ARTROMOT MULTI DIRECTIONAL ANKLE CPM1Cleared 510(K)
- K925666THERAPACER 30001Cleared 510(K)
- K924654FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT1Cleared 510(K)
- K925043ELBOW CPM ORTHOSIS1Cleared 510(K)
- K923857ARTROMOT SB ELBOW ATTACHMENT1Cleared 510(K)
- K923805POWER PILLOW1Cleared 510(K)
- K923494PARAMED LATERAL FLEXION MACHINE1Cleared 510(K)
- K921348OIC MODEL J4 TMJ CPM1Cleared 510(K)
- K923216DANNINFLEX CPM 8001Cleared 510(K)
- K923217DANNIFLEX CPM 20001Cleared 510(K)
- K922493AMERICAN MEDICAL MFG. LUMBAR CPM1Cleared 510(K)
- K922185JACE KNEE EXTENSION SYSTEM -- MODIFICATION1Cleared 510(K)
- K920686ORTHO-PLEX-REHABILITATION SYSTEM1Cleared 510(K)
- K921323CERVICAL PASSIVE MOTION1Cleared 510(K)
- K920860CONTROLLED PASSIVE MOTION MACHINE1Cleared 510(K)
- K920519LUMBAR CPM1Cleared 510(K)
- K920270CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY1Cleared 510(K)
- K920380JACE MODEL W550 WRIST CPM DEVICE1Cleared 510(K)
- K914860SUTTER MODEL 10000 LEG CPM DEVICE1Cleared 510(K)
- K914394BACK MASTER1Cleared 510(K)
- K913227JACE MODEL T300 TOE CPM DEVICE1Cleared 510(K)
- K912537JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION1Cleared 510(K)
- K912086FMA TRANSLATOR1Cleared 510(K)
- K904963EXTEND TRACK UNIT1Cleared 510(K)
- K905718ROMFLEX1Cleared 510(K)
- K904735DANNIFLEX MODEL 500TM CPM1Cleared 510(K)
- K910150ROMFLEX REHAB EQUIP EXTREMITIES UNIT1Cleared 510(K)
- K910149ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT1Cleared 510(K)
- K910151ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT1Cleared 510(K)
- K910026ATI MEDICAL COMFORT PLUS CPM PAD1Cleared 510(K)
- K905299ROMFLEX REHABILITATION EQUIPMENT1Cleared 510(K)
- K893924MOTO-MED RF-II AND PICO1Cleared 510(K)
- K903851CLUB FOOT CPM MACHINE1Cleared 510(K)
- K903467JACE MODEL 100 KNEE CPM DEVICE1Cleared 510(K)
- K902707MODEL 9000 AT ANKLE CPM DEVICE1Cleared 510(K)
- K902452CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER1Cleared 510(K)
- K900795MOBILIMB L4 LOWER LIMB CPM UNIT1Cleared 510(K)
- K900466MOBILIMB W1 WRIST CPM UNIT1Cleared 510(K)
- K895720MOBILIMB J1 TMJ CPM UNIT1Cleared 510(K)
- K894907MARK IV HAND, THUMB AND WRIST (CPM) UNIT1Cleared 510(K)
- K895015ARTROMOT(TM) CPM DEVICES1Cleared 510(K)
- K891345MOBILIMB CPM SHOULDER UNIT1Cleared 510(K)
- K890838REHABOT-YM1Cleared 510(K)
- K885182TOTAL KNEE CPM1Cleared 510(K)
- K890607SUTTER HOSPITAL CPM1Cleared 510(K)
- K885095SUPREME TONING SYSTEMS1Cleared 510(K)
- K890200PNEUMATIC DORSIFLEXOR1Cleared 510(K)
- K881314PROMO-RIST C.P.M.1Cleared 510(K)
- K882406CONVA-LIFT1Cleared 510(K)
- K882916MOTORIZED PARALLEL BAR, MODEL 1101Cleared 510(K)
- K880865RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT13001Cleared 510(K)
- K873658ANKLE REFLEX TREATMENT UNIT (ARTU)1Cleared 510(K)
- K880092RESUBMITTED FITNESS UPPER BODY ERGOMETER #51001Cleared 510(K)
- K874884MEDTRONIC(R) ORTHOFLEX(TM)1Cleared 510(K)
- K872815TRANSJAW(TM)1Cleared 510(K)
- K874196POWER EXERCISE EQUIPMENT1Cleared 510(K)
- K872638MOTORIZED TREADMILL MODEL #FT22001Cleared 510(K)
- K872639DELUXE MOTORIZED TREADMILL MODEL #FT23001Cleared 510(K)
- K872586ERGOMETRIC MOTORIZED TREADMILL MODEL #FT24001Cleared 510(K)
- K871981BILATERAL CONTINUOUS PASSIVE MOTION DEVICE1Cleared 510(K)
- K871012CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD1Cleared 510(K)
- K870402MOBILIMB HAND EXERCISER1Cleared 510(K)
- K870510DANNIFLEX 400I1Cleared 510(K)
- K864427KNEECPM1Cleared 510(K)
- K863639ARTICULAR MOTION DEVICE (AMD4000)1Cleared 510(K)
- K862730DANNIFLEX 400SL1Cleared 510(K)
- K862093GINGERBREAD MAN (TM)1Cleared 510(K)
- K862314HIP CONTINUOUS PASSIVE MOTION MACHINE1Cleared 510(K)
- K854354THE BLEDSOE PASSIVE MOTION EXERCISER1Cleared 510(K)
- K852977KNEE MACHINE1Cleared 510(K)
- K852399TOTAL CPM1Cleared 510(K)
- K852065PRESTON LOWER LIMB CPM UNIT1Cleared 510(K)
- K851331EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)1Cleared 510(K)
- K851177UNIVERSAL POWER FLEX1Cleared 510(K)
- K844779HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL1Cleared 510(K)
- K850871TREDBAND TYPE I, IT, II & III - TREADMILLS1Cleared 510(K)
- K844118THERAPEUTIC LIMB MANIPULATOR1Cleared 510(K)
- K850332KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE1Cleared 510(K)
- K850274SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT1Cleared 510(K)
- K850030CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE1Cleared 510(K)
- K844995SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE1Cleared 510(K)
- K843309UNIFLEX DANNINGER1Cleared 510(K)
- K843493PATIENT GUIDED KNEE EXERCISER1Cleared 510(K)
- K842882ANKLE MOBILIZER1Cleared 510(K)
- K842881KNEE-HIP MOBILIZER1Cleared 510(K)
- K842433ALLIED ASSOC. THERAPEUTIC EXERCISE1Cleared 510(K)
- K842430ALLIED ASSOC. THERAP. EXERCISE EQUIP1Cleared 510(K)
- K842429ALLIED ASSOC. THERAPEUTIC EXER EQUIP-1Cleared 510(K)
- K842431ALLIED ASSOC. THERAP. EXERCISE EQUIP-1Cleared 510(K)
- K842428ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP1Cleared 510(K)
- K842427ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP1Cleared 510(K)
- K842426ALLIED ASSOC. THERAPEUTIC EXERICSE1Cleared 510(K)
- K842425ALLIED ASSOCIATES THERAPEUTIC EXERCISE1Cleared 510(K)
- K842432ALLIED ASSOCIATES THERAPEUTIC EXERSIE1Cleared 510(K)
- K841674CONTINUOUS PASSIVE MOTION1Cleared 510(K)
- K841413HYDRA-GYM ATHLETICS INC.1Cleared 510(K)
- K834203FLEXXR* CPM SYSTEM1Cleared 510(K)
- K831910STRYKER LEG EXERCISER1Cleared 510(K)
- K830793PATIENT GUIDED ELBOW & SHOULDER EXERC1Cleared 510(K)
- K830316UNIFLEX1Cleared 510(K)
- K830649SUTTER CPM 20001Cleared 510(K)
- K830369POWER FLEX1Cleared 510(K)
- K830122CONTINUOUS ANATOMICAL PASSIVE EXERCISER1Cleared 510(K)
- K823495MOBILIMB-CPM UPPER/LOWER LIMB DEVICE1Cleared 510(K)
- K823539SUTTER CPM1Cleared 510(K)
- K822212MOTORIZED EXERCISER1Cleared 510(K)
- K822031AUTORANGE MODEL 2051Cleared 510(K)
- K821016QUADRUPLE JOGGER EXERCISER1Cleared 510(K)
- K820476KEM-21Cleared 510(K)
- K820120PATIENT GUIDED KNEE EXERCISER1Cleared 510(K)
- K820083SUTTER CPM1Cleared 510(K)
- K810238SUPINE STRESS SYSTEM1Cleared 510(K)
- K800007WORK SIMULATOR1Cleared 510(K)
- 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
ROMFLEX REHABILITATION EQUIPMENT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K905299
- 510(k) Type
- Traditional
- Applicant
- DYNA FLEX, INTL.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/31/1990
- Days to Decision
- 33 days