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
- K233006MyndMove, MyndMove 2.02Cleared 510(K)
- K230997EvoWalk 1.0 System2Cleared 510(K)
- K221823Cionic Neural Sleeve NS-1002Cleared 510(K)
- K213925MyoCycle MC-2 (Home / Home + / Pro / Pro +)2Cleared 510(K)
- K212149MyndMove 2.02Cleared 510(K)
- K213622Cionic Neural Sleeve NS-1002Cleared 510(K)
- K202110MStim Drop Model: LGT-2332Cleared 510(K)
- K193276Nerve and Muscle Stimulator2Cleared 510(K)
- K200262L100 Go System2Cleared 510(K)
- K191587L360 Thigh System2Cleared 510(K)
- K190285L300 Go System2Cleared 510(K)
- K173682L300 Go System2Cleared 510(K)
- K171396ODFS Pace XL2Cleared 510(K)
- K162718Foot Drop System (Model XFT-2001D)2Cleared 510(K)
- K170564MyndMove System, MyndMove Functional Electrical Stimulator2Cleared 510(K)
- K162470RT300 FES cycle ergometer2Cleared 510(K)
- K170132MyoCycle Home, MyoCycle Pro2Cleared 510(K)
- K162683RehaStim 22Cleared 510(K)
- K162407L300 Go System2Cleared 510(K)
- K153163ReGrasp2Cleared 510(K)
- K141812MYGAIT STIMULATION SYSTEM2Cleared 510(K)
- K140886WALKAIDE SYSTEM2Cleared 510(K)
- K131923NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS2Cleared 510(K)
- K132416REHASTIM 2, ERIGOPRO (FES)2Cleared 510(K)
- K123636H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE2Cleared 510(K)
- K123972WALKAIDE SYSTEM2Cleared 510(K)
- K122784NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT2Cleared 510(K)
- K120853NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,2Cleared 510(K)
- K112844REHASTIM 2, REHAMOVE 22Cleared 510(K)
- K111767NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT2Cleared 510(K)
- K103343L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)2Cleared 510(K)
- K103370RT2002Cleared 510(K)
- K103366RT6002Cleared 510(K)
- K102115ODFS PACE2Cleared 510(K)
- K090750RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA1045812Cleared 510(K)
- K080219MODIFICATION TO:NESS L3002Cleared 510(K)
- K073237REHASTIM & REHAMOVE2Cleared 510(K)
- K072398RT300-S AND RT300-SP FES CYCLE ERGOMETER2Cleared 510(K)
- K071486RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA1000532Cleared 510(K)
- K071113RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA1000532Cleared 510(K)
- K053468NESS L3002Cleared 510(K)
- K060032RT300-S, MODEL FA100052; RT300-SP, MODEL FA1000532Cleared 510(K)
- K052329WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-10002Cleared 510(K)
- K050991THE ODFS DROPPED FOOT STIMULATOR2Cleared 510(K)
- K050036FES CYCLE ERGOMETER, MODEL RT300-S2Cleared 510(K)
- K031900HANDMASTER2Cleared 510(K)
- K012823MODIFICATION TO HANDMASTER2Cleared 510(K)
- K010837HANDMASTER2Cleared 510(K)
- K974514EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K940759FORTE ES2Cleared 510(K)
- K911066COMFORTRON PT (TENS)2Cleared 510(K)
- K912615ROCHE COBAS ARGOS 5 DIFF2Cleared 510(K)
- K903434SELECT NEUROMUSCULAR STIMULATORS2Cleared 510(K)
- K873608TENS LEAD2Cleared 510(K)
- K813515VERI/DFS TM #8172Cleared 510(K)
- K800380FES ORTHOSIS MODEL NO. 20002Cleared 510(K)
- K770987NERVE STIMULATOR, MOLEL NO. FB-8002Cleared 510(K)
- K770725STIMULATOR, MUSCLE, MODEL 1072Cleared 510(K)
- 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
- 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
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product 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
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K103343
- 510(k) Type
- Traditional
- Applicant
- BIONESS INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/29/2011
- Days to Decision
- 165 days
- Submission Type
- Summary