TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
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.
§ 882.1455 - Traumatic brain injury eye movement assessment aid.
§ 882.1460 - Nystagmograph.
§ 882.1470 - Computerized cognitive assessment aid.
§ 882.1471 - Computerized cognitive assessment aid for concussion.
§ 882.1480 - Neurological endoscope.
§ 882.1491 - Pediatric Autism Spectrum Disorder diagnosis aid.
§ 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.
Subparts C-D [Reserved]
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.
§ 882.4950 - Diagnostic neurosurgical microscope filter.
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.
§ 882.5805 - 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.
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