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Title 21
PART 882 SUBPART f
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Volume 8
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Chapter I
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Subchapter H
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Part 882
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Subpart f
Subpart F - Neurological Therapeutic Devices
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
44 FR 51730, Sept. 4, 1979, unless otherwise noted.
21:8.0.1.1.28.5.1.1
SECTION 882.5030
882.5030 Methyl methacrylate for aneurysmorrhaphy.
21:8.0.1.1.28.5.1.2
SECTION 882.5050
882.5050 Biofeedback device.
21:8.0.1.1.28.5.1.3
SECTION 882.5070
882.5070 Bite block.
21:8.0.1.1.28.5.1.4
SECTION 882.5150
882.5150 Intravascular occluding catheter.
21:8.0.1.1.28.5.1.5
SECTION 882.5175
882.5175 Carotid artery clamp.
21:8.0.1.1.28.5.1.6
SECTION 882.5200
882.5200 Aneurysm clip.
21:8.0.1.1.28.5.1.7
SECTION 882.5225
882.5225 Implanted malleable clip.
21:8.0.1.1.28.5.1.8
SECTION 882.5235
882.5235 Aversive conditioning device.
21:8.0.1.1.28.5.1.9
SECTION 882.5250
882.5250 Burr hole cover.
21:8.0.1.1.28.5.1.10
SECTION 882.5275
882.5275 Nerve cuff.
21:8.0.1.1.28.5.1.11
SECTION 882.5300
882.5300 Methyl methacrylate for cranioplasty.
21:8.0.1.1.28.5.1.12
SECTION 882.5320
882.5320 Preformed alterable cranioplasty plate.
21:8.0.1.1.28.5.1.13
SECTION 882.5330
882.5330 Preformed nonalterable cranioplasty plate.
21:8.0.1.1.28.5.1.14
SECTION 882.5360
882.5360 Cranioplasty plate fastener.
21:8.0.1.1.28.5.1.15
SECTION 882.5500
882.5500 Lesion temperature monitor.
21:8.0.1.1.28.5.1.16
SECTION 882.5550
882.5550 Central nervous system fluid shunt and components.
21:8.0.1.1.28.5.1.17
SECTION 882.5600
882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
21:8.0.1.1.28.5.1.18
SECTION 882.5700
882.5700 Thermal system for insomnia.
21:8.0.1.1.28.5.1.19
SECTION 882.5800
882.5800 Cranial electrotherapy stimulator.
21:8.0.1.1.28.5.1.20
SECTION 882.5801
882.5801 Computerized behavioral therapy device for psychiatric disorders.
21:8.0.1.1.28.5.1.21
SECTION 882.5802
882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
21:8.0.1.1.28.5.1.22
SECTION 882.5805
882.5805 Repetitive transcranial magnetic stimulation system.
21:8.0.1.1.28.5.1.23
SECTION 882.5808
882.5808 Transcranial magnetic stimulator for headache.
21:8.0.1.1.28.5.1.24
SECTION 882.5810
882.5810 External functional neuromuscular stimulator.
21:8.0.1.1.28.5.1.25
SECTION 882.5820
882.5820 Implanted cerebellar stimulator.
21:8.0.1.1.28.5.1.26
SECTION 882.5830
882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
21:8.0.1.1.28.5.1.27
SECTION 882.5840
882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
21:8.0.1.1.28.5.1.28
SECTION 882.5850
882.5850 Implanted spinal cord stimulator for bladder evacuation.
21:8.0.1.1.28.5.1.29
SECTION 882.5860
882.5860 Implanted neuromuscular stimulator.
21:8.0.1.1.28.5.1.30
SECTION 882.5870
882.5870 Implanted peripheral nerve stimulator for pain relief.
21:8.0.1.1.28.5.1.31
SECTION 882.5880
882.5880 Implanted spinal cord stimulator for pain relief.
21:8.0.1.1.28.5.1.32
SECTION 882.5890
882.5890 Transcutaneous electrical nerve stimulator for pain relief.
21:8.0.1.1.28.5.1.33
SECTION 882.5891
882.5891 Transcutaneous electrical nerve stimulator to treat headache.
21:8.0.1.1.28.5.1.34
SECTION 882.5892
882.5892 External vagal nerve stimulator for headache.
21:8.0.1.1.28.5.1.35
SECTION 882.5893
882.5893 Thermal vestibular stimulator for headache.
21:8.0.1.1.28.5.1.36
SECTION 882.5894
882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
21:8.0.1.1.28.5.1.37
SECTION 882.5895
882.5895 Vibratory counter-stimulation device.
21:8.0.1.1.28.5.1.38
SECTION 882.5896
882.5896 Percutaneous nerve stimulator for substance use disorders.
21:8.0.1.1.28.5.1.39
SECTION 882.5900
882.5900 Preformed craniosynostosis strip.
21:8.0.1.1.28.5.1.40
SECTION 882.5897
882.5897 External upper limb tremor stimulator.
21:8.0.1.1.28.5.1.41
SECTION 882.5910
882.5910 Dura substitute.
21:8.0.1.1.28.5.1.42
SECTION 882.5940
882.5940 Electroconvulsive therapy device.
21:8.0.1.1.28.5.1.43
SECTION 882.5950
882.5950 Neurovascular embolization device.
21:8.0.1.1.28.5.1.44
SECTION 882.5960
882.5960 Skull tongs for traction.
21:8.0.1.1.28.5.1.45
SECTION 882.5970
882.5970 Cranial orthosis.
21:8.0.1.1.28.5.1.46
SECTION 882.5975
882.5975 Human dura mater.