Part 882 - NEUROLOGICAL DEVICES  


Subparts C-D [Reserved]
Subparts C–D [Reserved]
Subpart A — General Provisions
§ 882.1 Scope.
§ 882.3 Effective dates of requirement for premarket approval.
§ 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B — Neurological Diagnostic Devices
§ 882.1020 Rigidity analyzer.
§ 882.1030 Ataxiagraph.
§ 882.1200 Two-point discriminator.
§ 882.1240 Echoencephalograph.
§ 882.1275 Electroconductive media.
§ 882.1310 Cortical electrode.
§ 882.1320 Cutaneous electrode.
§ 882.1330 Depth electrode.
§ 882.1340 Nasopharyngeal electrode.
§ 882.1350 Needle electrode.
§ 882.1400 Electroencephalograph.
§ 882.1410 Electroencephalograph electrode/lead tester.
§ 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
§ 882.1430 Electroencephalograph test signal generator.
§ 882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.
§ 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
§ 882.1460 Nystagmograph.
§ 882.1470 Computerized cognitive assessment aid.
§ 882.1471 Computerized cognitive assessment aid for concussion.
§ 882.1480 Neurological endoscope.
§ 882.1500 Esthesiometer.
§ 882.1525 Tuning fork.
§ 882.1540 Galvanic skin response measurement device.
§ 882.1550 Nerve conduction velocity measurement device.
§ 882.1560 Skin potential measurement device.
§ 882.1561 Evoked photon image capture device.
§ 882.1570 Powered direct-contact temperature measurement device.
§ 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
§ 882.1610 Alpha monitor.
§ 882.1620 Intracranial pressure monitoring device.
§ 882.1630 Cranial motion measurement device.
§ 882.1700 Percussor.
§ 882.1750 Pinwheel.
§ 882.1790 Ocular plethysmograph.
§ 882.1825 Rheoencephalograph.
§ 882.1835 Physiological signal amplifier.
§ 882.1845 Physiological signal conditioner.
§ 882.1855 Electroencephalogram (EEG) telemetry system.
§ 882.1870 Evoked response electrical stimulator.
§ 882.1880 Evoked response mechanical stimulator.
§ 882.1890 Evoked response photic stimulator.
§ 882.1900 Evoked response auditory stimulator.
§ 882.1925 Ultrasonic scanner calibration test block.
§ 882.1935 Near Infrared (NIR) Brain Hematoma Detector.
§ 882.1950 Tremor transducer.
Subpart E — Neurological Surgical Devices
§ 882.4030 Skull plate anvil.
§ 882.4060 Ventricular cannula.
§ 882.4100 Ventricular catheter.
§ 882.4125 Neurosurgical chair.
§ 882.4150 Scalp clip.
§ 882.4175 Aneurysm clip applier.
§ 882.4190 Clip forming/cutting instrument.
§ 882.4200 Clip removal instrument.
§ 882.4215 Clip rack.
§ 882.4250 Cryogenic surgical device.
§ 882.4275 Dowel cutting instrument.
§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
§ 882.4325 Cranial drill handpiece (brace).
§ 882.4360 Electric cranial drill motor.
§ 882.4370 Pneumatic cranial drill motor.
§ 882.4400 Radiofrequency lesion generator.
§ 882.4440 Neurosurgical headrests.
§ 882.4460 Neurosurgical head holder (skull clamp).
§ 882.4500 Cranioplasty material forming instrument.
§ 882.4525 Microsurgical instrument.
§ 882.4535 Nonpowered neurosurgical instrument.
§ 882.4545 Shunt system implantation instrument.
§ 882.4560 Stereotaxic instrument.
§ 882.4600 Leukotome.
§ 882.4650 Neurosurgical suture needle.
§ 882.4700 Neurosurgical paddie.
§ 882.4725 Radiofrequency lesion probe.
§ 882.4750 Skull punch.
§ 882.4800 Self-retaining retractor for neurosurgery.
§ 882.4840 Manual rongeur.
§ 882.4845 Powered rongeur.
§ 882.4900 Skullplate screwdriver.
Subpart F — Neurological Therapeutic Devices
§ 882.5030 Methyl methacrylate for aneurysmorrhaphy.
§ 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.
§ 882.5300 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.
§ 882.5600 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.
§ 882.5802 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.
§ 882.5830 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.
§ 882.5870 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.
§ 882.5900 Preformed craniosynostosis strip.
§ 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.

Authority

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

Source

44 FR 51730, Sept. 4, 1979, unless otherwise noted.

EditorNote

, Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.