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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 882 - Neurological Devices |
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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. |
| § 882.5975 - Human dura mater. |