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Neurological Therapeutic Devices
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Medical Devices
Neurological Devices
Neurological Therapeutic Devices
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Section
882.5030
Methyl methacrylate for aneurysmorrhaphy.
Section
882.5050
Biofeedback device.
Section
882.5060
Conditioning tool for eating disorders.
Section
882.5070
Bite block.
Section
882.5150
Intravascular occluding catheter.
Section
882.5175
Carotid artery clamp.
Section
882.5200
Aneurysm clip.
Section
882.5225
Implanted malleable clip.
Section
882.5235
Aversive conditioning device.
Section
882.5250
Burr hole cover.
Section
882.5275
Nerve cuff.
Section
882.5300
Methyl methacrylate for cranioplasty.
Section
882.5320
Preformed alterable cranioplasty plate.
Section
882.5330
Preformed nonalterable cranioplasty plate.
Section
882.5360
Cranioplasty plate fastener.
Section
882.5500
Lesion temperature monitor.
Section
882.5550
Central nervous system fluid shunt and components.
Section
882.5560
Cerebrospinal fluid shunt system.
Section
882.5600
Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
Section
882.5700
Thermal system for insomnia.
Section
882.5800
Cranial electrotherapy stimulator.
Section
882.5801
Computerized behavioral therapy device for psychiatric disorders.
Section
882.5802
Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Section
882.5805
Repetitive transcranial magnetic stimulation system.
Section
882.5808
Transcranial magnetic stimulator for headache.
Section
882.5810
External functional neuromuscular stimulator.
Section
882.5820
Implanted cerebellar stimulator.
Section
882.5830
Implanted diaphragmatic/phrenic nerve stimulator.
Section
882.5840
Implanted intracerebral/subcortical stimulator for pain relief.
Section
882.5850
Implanted spinal cord stimulator for bladder evacuation.
Section
882.5860
Implanted neuromuscular stimulator.
Section
882.5870
Implanted peripheral nerve stimulator for pain relief.
Section
882.5880
Implanted spinal cord stimulator for pain relief.
Section
882.5898
Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
Section
882.5899
Trunk and limb electrical stimulator to treat headache.
Section
882.5890
Transcutaneous electrical nerve stimulator for pain relief.
Section
882.5891
Transcutaneous electrical nerve stimulator to treat headache.
Section
882.5892
External vagal nerve stimulator for headache.
Section
882.5893
Thermal vestibular stimulator for headache.
Section
882.5894
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
Section
882.5895
Vibratory counter-stimulation device.
Section
882.5896
Percutaneous nerve stimulator for substance use disorders.
Section
882.5900
Preformed craniosynostosis strip.
Section
882.5897
External upper limb tremor stimulator.
Section
882.5910
Dura substitute.
Section
882.5940
Electroconvulsive therapy device.
Section
882.5950
Neurovascular embolization device.
Section
882.5955
Temporary coil embolization assist device.
Section
882.5960
Skull tongs for traction.
Section
882.5970
Cranial orthosis.