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
- LEMHuman Lyophilized Dura Mater2Product Code
- LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief3Product Code
- LHYElectrode, Stabilized Epidural Spinal3Product Code
- LIIMonitor, Intracranial Pressure, Implanted3Product Code
- LKWLaser, Neurosurgical3Product Code
- LLEStimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease3Product Code
- LLFLaser, Neurosurgical, Argon3Product Code
- LLPLaser For Pain Therapy3Product Code
- LMEMonitor, Blood-Flow, Cerebral, Thermal Diffusion3Product Code
- LQDRecorder, Attention Task PerformanceUProduct Code
- LYIStimulator, Subcortical, Implanted For Epilepsy3Product Code
- LYJStimulator, Autonomic Nerve, Implanted For Epilepsy3Product Code
- MBXStimulator, Thalamic, Epilepsy, Implanted3Product Code
- BWKStimulator, Electro-AcupunctureUProduct Code
- K244030Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)UCleared 510(K)
- K220153Needle Stimulator (Model: RJNS6-1)UCleared 510(K)
- K202861Needle StimulatorUCleared 510(K)
- K200636AXUS ES-5 Electro-Acupuncture DeviceUCleared 510(K)
- K170391ANSiStim-PPUCleared 510(K)
- K152571StivaxUCleared 510(K)
- K141168ANSISTIMUCleared 510(K)
- K133980PANTHEON ELECTROSTIMULATORUCleared 510(K)
- K140530Electro Auricular DeviceUCleared 510(K)
- K140788P-STIMUCleared 510(K)
- K130768JIAJIAN CMN STIMULATORUCleared 510(K)
- K122812JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORSUCleared 510(K)
- K093322MULTI-PURPOSE HEALTH DEVICEUCleared 510(K)
- K091933ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01UCleared 510(K)
- K091875E-PULSEUCleared 510(K)
- K081943MODEL ES-130UCleared 510(K)
- K050123P-STIM SYSTEMUCleared 510(K)
- K051197ACULIFE, MODEL SMW-01UCleared 510(K)
- K014273ACUSTIMUCleared 510(K)
- K840995ACUPUNCTURE INSOLESUCleared 510(K)
- K840983PULSELIFE STIMULATORUCleared 510(K)
- K832634SELECTRODE SYSTEMUCleared 510(K)
- K781651HEALTH POINTUCleared 510(K)
- KGFAdhesive, Tissue For Aneurysmorrhaphy3Product Code
- QCFNeuromuscular Tongue Stimulator To Treat Motor Deficits2Product Code
- KGGTissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations3Product Code
- LBKDevice, Neurosurgical Fragmentation And AspirationUProduct Code
- MFEAgent, Injectable, Embolic3Product Code
- MFRStimulator, Brain, Implanted, For Behavior ModificationFProduct Code
- MHYStimulator, Electrical, Implanted, For Parkinsonian Tremor3Product Code
- MHZStimulator, Vestibular Acceleration, Therapeutic3Product Code
- MKDStimulator, Functional Walking Neuromuscular, Non-Invasive3Product Code
- MLQInhibitor, Peridural Fibrosis (Adhesion Barrier)3Product Code
- MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)FProduct Code
- MUZStimulator, Autonomic Nerve, Implanted (Depression)3Product Code
- MVVDevice, AcupressureUProduct Code
- MXMCap, Cooling (Infants)3Product Code
- NHLStimulator, Electrical, Implanted, For Parkinsonian Symptoms3Product Code
- NJEIntracranial Neurovascular StentFProduct Code
- NPEMaterial, Embolization, Neurovascular, Polymerizing Or Precipitating3Product Code
- NQRSealant, Dural3Product Code
- NZKStimulator, Low Electric Field, Tumor Treatment3Product Code
- OBAPolymerizing, Neurovascular Embolization MaterialFProduct Code
- OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)FProduct Code
- OPRIntrasaccular Flow Disruption Device3Product Code
- OUTIntracranial Aneurysm Flow Diverter3Product Code
- OUUPolymeric Neurovascular EmbolizationFProduct Code
- OVCHeadframeNProduct Code
- OZJInhibitor, Postoperative Fibrosis (Adhesion Barrier)NProduct Code
- PAXSurgical KitFProduct Code
- PCQInhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)NProduct Code
- PFNImplanted Brain Stimulator For Epilepsy3Product Code
- PJSStimulator, Electrical, Implanted, For Essential Tremor3Product Code
- PMPDorsal Root Ganglion Stimulator For Pain Relief3Product Code
- POHMr-Guided Focused Ultrasound System3Product Code
- QCAIntracranial Coil-Assist Stent3Product Code
- QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief3Product Code
- QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy3Product Code
- QSLBrain Temperature Measurement System2Product Code
- QSQTranscutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms2Product Code
- QWDStimulator, Nerve, For Restless Legs Syndrome2Product Code
- QTKTemporary Percutaneous Transluminal Cerebral Artery Dilatation DeviceFProduct Code
- SAZStimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb3Product Code
- QWTPrognostic Assessment Software Of Mild Cognitive Impairment2Product Code
- SBGIn Situ Polymerizing Peripheral Nerve Cap2Product Code
- SDGBrain Intraparenchymal Infusion Cannula2Product Code
- SDXNeuromuscular Stimulator And Exercise Evaluation System2Product Code
- SEEComputerized Behavioral Therapy Device For Migraine2Product Code
- SEMSub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring2Product Code
- SFDIn Situ Polymerizing Peripheral Nerve Repair Device2Product Code
- SFNNon-Invasive Evoked Response Brain Stimulator2Product Code
- SFJVagus Nerve Stimulator For Rheumatoid Arthritis3Product Code
- Submissions with No Product CodeMiscellaneous
- 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
- 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
MODEL ES-130
- Page Type
- Cleared 510(K)
- 510(k) Number
- K081943
- 510(k) Type
- Traditional
- Applicant
- ITO CO., LTD.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/24/2008
- Days to Decision
- 139 days
- Submission Type
- Summary