21 CFR Subpart F
Neurological Therapeutic Devices
June 25, 2020
§
882.5360
Cranioplasty plate fastener
§
882.5500
Lesion temperature monitor
§
882.5890
Transcutaneous electrical nerve stimulator for pain relief
§
882.5891
Transcutaneous electrical nerve stimulator to treat headache
§
882.5900
Preformed craniosynostosis strip
§
882.5300
Methyl methacrylate for cranioplasty
§
882.5320
Preformed alterable cranioplasty plate
§
882.5030
Methyl methacrylate for aneurysmorrhaphy
§
882.5330
Preformed nonalterable cranioplasty plate
§
882.5050
Biofeedback device
§
882.5070
Bite block
§
882.5150
Intravascular occluding catheter
§
882.5175
Carotid artery clamp
§
882.5200
Aneurysm clip
§
882.5225
Implanted malleable clip
§
882.5235
Aversive conditioning device
§
882.5250
Burr hole cover
§
882.5275
Nerve cuff
§
882.5550
Central nervous system fluid shunt and components
§
882.5600
Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
§
882.5700
Thermal system for insomnia
§
882.5800
Cranial electrotherapy stimulator
§
882.5801
Computerized behavioral therapy device for psychiatric disorders
§
882.5870
Implanted peripheral nerve stimulator for pain relief
§
882.5802
Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions
§
882.5805
Repetitive transcranial magnetic stimulation system
§
882.5808
Transcranial magnetic stimulator for headache
§
882.5810
External functional neuromuscular stimulator
§
882.5820
Implanted cerebellar stimulator
§
882.5880
Implanted spinal cord stimulator for pain relief
§
882.5830
Implanted diaphragmatic/phrenic nerve stimulator
§
882.5840
Implanted intracerebral/subcortical stimulator for pain relief
§
882.5850
Implanted spinal cord stimulator for bladder evacuation
§
882.5860
Implanted neuromuscular stimulator
§
882.5892
External vagal nerve stimulator for headache
§
882.5893
Thermal vestibular stimulator for headache
§
882.5894
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites
§
882.5895
Vibratory counter-stimulation device
§
882.5896
Percutaneous nerve stimulator for substance use disorders
§
882.5897
External upper limb tremor stimulator
§
882.5910
Dura substitute
§
882.5940
Electroconvulsive therapy device
§
882.5950
Neurovascular embolization device
§
882.5960
Skull tongs for traction
§
882.5970
Cranial orthosis
§
882.5975
Human dura mater
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