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Regulations last checked for updates: Nov 22, 2024
Title 21 - Food and Drugs last revised: Nov 19, 2024
All Titles
Title 21
Chapter I
Part 882
Subpart F - Subpart F—Neurological Therapeutic Devices
§ 882.5030 - Methyl methacrylate for aneurysmorrhaphy.
§ 882.5050 - Biofeedback device.
§ 882.5060 - Conditioning tool for eating disorders.
§ 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.
§ 882.5300 - Methyl methacrylate for cranioplasty.
§ 882.5320 - Preformed alterable cranioplasty plate.
§ 882.5330 - Preformed nonalterable cranioplasty plate.
§ 882.5360 - Cranioplasty plate fastener.
§ 882.5500 - Lesion temperature monitor.
§ 882.5550 - Central nervous system fluid shunt and components.
§ 882.5560 - Cerebrospinal fluid shunt system.
§ 882.5600 - Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
§ 882.5700 - Thermal system for insomnia.
§ 882.5705 - Digital therapy device to reduce sleep disturbance for psychiatric conditions.
§ 882.5800 - Cranial electrotherapy stimulator.
§ 882.5801 - Computerized behavioral therapy device for psychiatric disorders.
§ 882.5802 - Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
§ 882.5803 - Digital therapy device for Attention Deficit Hyperactivity Disorder.
§ 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.
§ 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.
§ 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.
§ 882.5850 - Implanted spinal cord stimulator for bladder evacuation.
§ 882.5855 - Brain stimulation programming planning software.
§ 882.5860 - Implanted neuromuscular stimulator.
§ 882.5870 - Implanted peripheral nerve stimulator for pain relief.
§ 882.5880 - Implanted spinal cord stimulator for pain relief.
§ 882.5890 - Transcutaneous electrical nerve stimulator for pain relief.
§ 882.5891 - Transcutaneous electrical nerve stimulator to treat headache.
§ 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.
§ 882.5898 - Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
§ 882.5899 - Trunk and limb electrical stimulator to treat headache.
§ 882.5900 - Preformed craniosynostosis strip.
§ 882.5910 - Dura substitute.
§ 882.5940 - Electroconvulsive therapy device.
§ 882.5950 - Neurovascular embolization device.
§ 882.5955 - Temporary coil embolization assist device.
§ 882.5960 - Skull tongs for traction.
§ 882.5970 - Cranial orthosis.
authority:
21 U.S.C. 351
,
360
,
360
c,
360
e,
360
j,
360
source:
44 FR 51730, Sept. 4, 1979, unless otherwise noted.
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