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
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- K233580A Breathing System (ABS)2Cleared 510(K)
- K222101Prism2Cleared 510(K)
- K180173Freespira2Cleared 510(K)
- K163448GrindCare System2Cleared 510(K)
- K151050Pacifier Activated Lullaby (PAL®)2Cleared 510(K)
- K143507NFANT Feeding Solution2Cleared 510(K)
- K131586CANCARY BREATHING SYSTEM2Cleared 510(K)
- K122879EEGER4 MODEL 4.32Cleared 510(K)
- K111687EMG SYSTEM2Cleared 510(K)
- K092675GRINDCARE2Cleared 510(K)
- K073557EEG NEUROAMP, MODEL CS101372Cleared 510(K)
- K071866NTRAINER SYSTEM2Cleared 510(K)
- K071661ALPHAONE BIOFEEDBACK SYSTEM2Cleared 510(K)
- K041244POLYGRAM NET BIOFEEDBACK APPLICATION2Cleared 510(K)
- K020399RESPERATE; MODEL RR-1502Cleared 510(K)
- K010388SONDREX P.A.L. SYSTEM2Cleared 510(K)
- K013399MODEL MES-9000/EMG SYSTEM2Cleared 510(K)
- K012384EAR MUFFINS2Cleared 510(K)
- K012011MODIFICATION TO A620 EEG2Cleared 510(K)
- K011964INSIGHT MILLENNIUM PLUS2Cleared 510(K)
- K011823BIOREHAB SYSTEM2Cleared 510(K)
- K011983INSIGHT GENESIS2Cleared 510(K)
- K003367ORION PLATINUM2Cleared 510(K)
- K003127REGAIN DESKTOP2Cleared 510(K)
- K000405INTERCURE LTD. RESPI-LOW2Cleared 510(K)
- K993654NEUROCOMP2Cleared 510(K)
- K992439NORODYN 8000 SEMG SYSTEM, ND-80002Cleared 510(K)
- K990778INSIGHT MILLENNIUM2Cleared 510(K)
- K990538BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE2Cleared 510(K)
- K990356THE BAGNOLI-8 EMG SYSTEM2Cleared 510(K)
- K983550XYZ SYSTEM2Cleared 510(K)
- K981934THE BAGNOLI-4 EMG SYSTEM2Cleared 510(K)
- K981844SLEEP MANAGEMENT SYSTEM2Cleared 510(K)
- K980373ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE2Cleared 510(K)
- K971400MUSCLE RESPONSE MONITOR2Cleared 510(K)
- K971708PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE2Cleared 510(K)
- K973537PATHWAY ELECTROMYOGRAPH2Cleared 510(K)
- K972723BIO TROL2Cleared 510(K)
- K972487EMG RETRAINER2Cleared 510(K)
- K970051MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE2Cleared 510(K)
- K943535MODEL ME 300 MUSCLE TESTER2Cleared 510(K)
- K963202MEGA ME 3000 PROFESSIONAL MUSCLE TESTER2Cleared 510(K)
- K965006AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)2Cleared 510(K)
- K961645MRS-2D2Cleared 510(K)
- K961718DEI MODEL 20 EEG2Cleared 510(K)
- K960761PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-202Cleared 510(K)
- K954737SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE2Cleared 510(K)
- K960762SYNERGY PLUS2Cleared 510(K)
- K952797AT53 DUAL CHANNEL EMG2Cleared 510(K)
- K924313DIGITAL CONDUCTANCE METER2Cleared 510(K)
- K953257ORALSENSOR2Cleared 510(K)
- K954127BIOFEEDBACK DEVICE2Cleared 510(K)
- K951213RELAXPLUS2Cleared 510(K)
- K944615A620 EEG2Cleared 510(K)
- K945286THE BAGNOLI-2 EMG SYSTEM2Cleared 510(K)
- K942769BIOINTEGRATOR, BIOINTEGRATOR PLUS2Cleared 510(K)
- K945826J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS2Cleared 510(K)
- K951350MUSCLESENSE ELECTROMYOGRAPHY DEVICE2Cleared 510(K)
- K941959VERSATELL; VERSATELL-S2Cleared 510(K)
- K951969MYOEXORCISER II FUAL2Cleared 510(K)
- K930578AT33 EMG2Cleared 510(K)
- K930577AT64 SCR2Cleared 510(K)
- K930576AT422Cleared 510(K)
- K940050FOCUS EMG2Cleared 510(K)
- K920038NEUROSEARCH-42Cleared 510(K)
- K925750RELAXOMAT2Cleared 510(K)
- K935853EMG TRAINER2Cleared 510(K)
- K922270PHYSIOTECH 4000 OR NORODYN 80002Cleared 510(K)
- K941938THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE2Cleared 510(K)
- K914925MEDAC SYSTEM/32Cleared 510(K)
- K922838NORODYN 2000 ELECTROMYOGRAPH2Cleared 510(K)
- K925197PSI 220 DUAL EMG2Cleared 510(K)
- K914920BIOFEEDBACK SYSTEM/32Cleared 510(K)
- K915859MYOTRAC/S, MYODAC/S2Cleared 510(K)
- K915858MYOTRAC22Cleared 510(K)
- K913898MYOTRAC+/S, MYODAC+/S2Cleared 510(K)
- K911911MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM2Cleared 510(K)
- K912595AXIOM ELECTROMYOGRAPH2Cleared 510(K)
- K897132PATHWAY II ELECTROMYOGRAPH2Cleared 510(K)
- K905372MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-0022Cleared 510(K)
- K905373MINIATURE TEMPERATURE TRAINER MODEL DT-0022Cleared 510(K)
- K903497FLEXCOMP DSP & PROCOMP2Cleared 510(K)
- K902450BODYLOG ENHANCED STRESS REDUCTION PACKAGE2Cleared 510(K)
- K896409M(3):MICRO MUSCLE MONITOR2Cleared 510(K)
- K900639DYNATRON 350 EMG/BIOFEEDBACK ANALYZER2Cleared 510(K)
- K895635MYOSYSTEM 1000 ELECTROMYOGRAPH2Cleared 510(K)
- K895633MYOTRACE 10 BIOFEEDBACK DEVICE2Cleared 510(K)
- K894510BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH2Cleared 510(K)
- K890500ELT OR ERGONOMIC LIFT TRAINER2Cleared 510(K)
- K892649VERIMED MYOEXORCISER III (MYO III)2Cleared 510(K)
- K894840MYODAC2 BIOFEEDBACK DEVICE2Cleared 510(K)
- K892114ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM2Cleared 510(K)
- K891693AUTOMATED THERAPY SYSTEM2Cleared 510(K)
- K881164LEUNOMED RFB 50002Cleared 510(K)
- K884849BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR2Cleared 510(K)
- K884851BIOFEEDBACK DEVICE TG3, TG42Cleared 510(K)
- K884852BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.2Cleared 510(K)
- K884853BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC12Cleared 510(K)
- K884848BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV2Cleared 510(K)
- K884850BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA302Cleared 510(K)
- K884135DM100 (DISTAL MONITOR - 100)2Cleared 510(K)
- K883597MYODAC2Cleared 510(K)
- K881416MYOTRAC2Cleared 510(K)
- K882266DIGITAL EMG MONITOR MYOTRON 1202Cleared 510(K)
- K882062MODEL BIOSTAR2Cleared 510(K)
- K880916M444 EMG MONITOR2Cleared 510(K)
- K880913M424 EMG MONITOR2Cleared 510(K)
- K880914T824 TEMPERATURE MONITOR2Cleared 510(K)
- K873834INET MODEL BIOVISION2Cleared 510(K)
- K875308PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 4212Cleared 510(K)
- K873418BODYLOG STRESS REDUCTION PACKAGE2Cleared 510(K)
- K872495BIOCOMP 2001 BIOFEEDBACK DEVICE2Cleared 510(K)
- K870568BIO-PROMPT(TM)2Cleared 510(K)
- K870793SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE2Cleared 510(K)
- K861950THE FM-212A BIOFEEDBACK UNIT2Cleared 510(K)
- K860271BIOFEEDBACK MICROLAB2Cleared 510(K)
- K854277NEUROPATH 40002Cleared 510(K)
- K852963MYO-ACTUATOR2Cleared 510(K)
- K854208THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS2Cleared 510(K)
- K853806MA-400 EMB FEEDBACK DEVICE2Cleared 510(K)
- K850849MYOMETER EMG BIOFEEDBACK DEVICE2Cleared 510(K)
- K850759COMPUTER INTERFACE - BIOFEEDBACK2Cleared 510(K)
- K850643HR/BVP 100T HEART RATE MONITOR2Cleared 510(K)
- K850642TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA2Cleared 510(K)
- K843738CAB2 COMPUTER ASSISTED BIOFEEDBACK2Cleared 510(K)
- K843413STRESS CONTROL BIOFEEDBACK CARD2Cleared 510(K)
- K842021EEG BIOFEEDBACK DEVICE ACCESSORY2Cleared 510(K)
- K842023TEMP. & GSR BIOFEEDBACK DEVICE2Cleared 510(K)
- K842022EEG BIOFEEDBACK DEVICE2Cleared 510(K)
- K842354EMG MODEL 1332Cleared 510(K)
- K841895GSR, 126, EEG 130-TEMP. 132, EMG 1332Cleared 510(K)
- K842353TEMPERATURE 1322Cleared 510(K)
- K842288EEG 1302Cleared 510(K)
- K841128RELAX STRESS REDUCTION SYS2Cleared 510(K)
- K840223ORION BIOFEEDBACK DATA ACQUISITION2Cleared 510(K)
- K834110ANTENSE ANTI-TENSION DEVICE2Cleared 510(K)
- K834111ANTACHE ANTI-HEADACHE DEVICE2Cleared 510(K)
- K834519CALMTONE2Cleared 510(K)
- K832714VERIMED MYOEXORCISER2Cleared 510(K)
- K832333FEEDBACK EMG SYSTEM PE-0202Cleared 510(K)
- K832146TA-400 TEMP. FEEDBACK DEVICE2Cleared 510(K)
- K832122ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED2Cleared 510(K)
- K823511EMG BIOFEEDBACK DEVICE2Cleared 510(K)
- K830529BIOFEEDBACK-TRAINING INSTRUMENT2Cleared 510(K)
- K823381PROFESSIONAL MARK I BIOFEEDBACK SYS2Cleared 510(K)
- K823146CALMSET 3 TM2Cleared 510(K)
- K822814EMG 100T2Cleared 510(K)
- K812619ISOLATED VOLTAGE/FREQUENCY CONVERTER2Cleared 510(K)
- K812179LIFE-TECH #1753 BIOFEEDBACK TRAINER2Cleared 510(K)
- K810880AR-1 PHYSIOLOGICAL PRODESSOR2Cleared 510(K)
- K810882ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A2Cleared 510(K)
- K810881EMG 3510/EMG 3510D MYOFEEDBACK MONITORS2Cleared 510(K)
- K810332SC/TEMP 3002Cleared 510(K)
- K803099BIOFEEDBACK BIO 802Cleared 510(K)
- K802391EMG-UT 402Cleared 510(K)
- K802390EMG-UT 302Cleared 510(K)
- K801049V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU2Cleared 510(K)
- K800319ALPHA DETECTOR2Cleared 510(K)
- K792115BIOFEEDBACK DEVICES & ACCESSORIES2Cleared 510(K)
- K792659FEEDBACK EDR SYSTEM MODEL ME-12Cleared 510(K)
- K791207APOLLO HEART RATE INDICATOR2Cleared 510(K)
- K790746THE BIONIC EXERCISER2Cleared 510(K)
- K781634VISUALAX2Cleared 510(K)
- K780436RELAX-A-TONE2Cleared 510(K)
- K771577CLINICAL EMG MODEL 1332Cleared 510(K)
- K771023ANALOG QUANTIFIER MODEL AQ-1002Cleared 510(K)
- K770787RELAXATION COURSE MOLEL 10002Cleared 510(K)
- K770790FEEDBACK EDR SYSTEM MODEL EDR-1002Cleared 510(K)
- K770663FEEDBACK EMG SYSTEM, MODEL PE-L002Cleared 510(K)
- K761350MYOTRON2Cleared 510(K)
- K770270TEMPERATURE FEEDBACK SYS, MODEL DT1002Cleared 510(K)
- K760084MONITOR, GSR (NB-401)2Cleared 510(K)
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- MVAOrthosis, Cranial2Product Code
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- SCPComputerized Behavioral Therapy Device For Anxiety Disorders2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
INSIGHT GENESIS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K011983
- 510(k) Type
- Traditional
- Applicant
- FASSTECH
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/30/2001
- Days to Decision
- 65 days
- Submission Type
- Summary