Home/CFR/Title 21/Part 882
FEDERAL · 21 CFR

Part 882 — Neurological Devices

140 sections · Title 21: Food and Drugs

§ 882.1Scope.
§ 882.3Effective dates of requirement for premarket approval.
§ 882.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 882.1020Rigidity analyzer.
§ 882.1030Ataxiagraph.
§ 882.1200Two-point discriminator.
§ 882.1240Echoencephalograph.
§ 882.1275Electroconductive media.
§ 882.1310Cortical electrode.
§ 882.1320Cutaneous electrode.
§ 882.1330Depth electrode.
§ 882.1340Nasopharyngeal electrode.
§ 882.1350Needle electrode.
§ 882.1400Electroencephalograph.
§ 882.1410Electroencephalograph electrode/lead tester.
§ 882.1420Electroencephalogram (EEG) signal spectrum analyzer.
§ 882.1430Electroencephalograph test signal generator.
§ 882.1440Neuropsychiatric interpretive electroencephalograph assessment aid.
§ 882.1450Brain injury adjunctive interpretive electroencephalograph assessment aid.
§ 882.1455Traumatic brain injury eye movement assessment aid.
§ 882.1460Nystagmograph.
§ 882.1470Computerized cognitive assessment aid.
§ 882.1471Computerized cognitive assessment aid for concussion.
§ 882.1480Neurological endoscope.
§ 882.1491Pediatric Autism Spectrum Disorder diagnosis aid.
§ 882.1500Esthesiometer.
§ 882.1525Tuning fork.
§ 882.1540Galvanic skin response measurement device.
§ 882.1550Nerve conduction velocity measurement device.
§ 882.1560Skin potential measurement device.
§ 882.1561Evoked photon image capture device.
§ 882.1570Powered direct-contact temperature measurement device.
§ 882.1580Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
§ 882.1610Alpha monitor.
§ 882.1620Intracranial pressure monitoring device.
§ 882.1630Cranial motion measurement device.
§ 882.1700Percussor.
§ 882.1750Pinwheel.
§ 882.1790Ocular plethysmograph.
§ 882.1825Rheoencephalograph.
§ 882.1835Physiological signal amplifier.
§ 882.1845Physiological signal conditioner.
§ 882.1855Electroencephalogram (EEG) telemetry system.
§ 882.1870Evoked response electrical stimulator.
§ 882.1880Evoked response mechanical stimulator.
§ 882.1890Evoked response photic stimulator.
§ 882.1900Evoked response auditory stimulator.
§ 882.1925Ultrasonic scanner calibration test block.
§ 882.1935Near Infrared (NIR) Brain Hematoma Detector.
§ 882.1950Tremor transducer.
§ 882.4030Skull plate anvil.
§ 882.4060Ventricular cannula.
§ 882.4100Ventricular catheter.
§ 882.4125Neurosurgical chair.
§ 882.4150Scalp clip.
§ 882.4175Aneurysm clip applier.
§ 882.4190Clip forming/cutting instrument.
§ 882.4200Clip removal instrument.
§ 882.4215Clip rack.
§ 882.4250Cryogenic surgical device.
§ 882.4275Dowel cutting instrument.
§ 882.4300Manual cranial drills, burrs, trephines, and their accessories
§ 882.4305Powered compound cranial drills, burrs, trephines, and their accessories.
§ 882.4310Powered simple cranial drills, burrs, trephines, and their accessories.
§ 882.4325Cranial drill handpiece (brace).
§ 882.4360Electric cranial drill motor.
§ 882.4370Pneumatic cranial drill motor.
§ 882.4400Radiofrequency lesion generator.
§ 882.4440Neurosurgical headrests.
§ 882.4460Neurosurgical head holder (skull clamp).
§ 882.4500Cranioplasty material forming instrument.
§ 882.4525Microsurgical instrument.
§ 882.4535Nonpowered neurosurgical instrument.
§ 882.4545Shunt system implantation instrument.
§ 882.4560Stereotaxic instrument.
§ 882.4565Field generator positioning device.
§ 882.4600Leukotome.
§ 882.4650Neurosurgical suture needle.
§ 882.4700Neurosurgical paddie.
§ 882.4725Radiofrequency lesion probe.
§ 882.4750Skull punch.
§ 882.4800Self-retaining retractor for neurosurgery.
§ 882.4840Manual rongeur.
§ 882.4845Powered rongeur.
§ 882.4900Skullplate screwdriver.
§ 882.4950Diagnostic neurosurgical microscope filter.
§ 882.5030Methyl methacrylate for aneurysmorrhaphy.
§ 882.5050Biofeedback device.
§ 882.5060Conditioning tool for eating disorders.
§ 882.5070Bite block.
§ 882.5150Intravascular occluding catheter.
§ 882.5175Carotid artery clamp.
§ 882.5200Aneurysm clip.
§ 882.5225Implanted malleable clip.
§ 882.5235Aversive conditioning device.
§ 882.5250Burr hole cover.
§ 882.5275Nerve cuff.
§ 882.5300Methyl methacrylate for cranioplasty.
§ 882.5320Preformed alterable cranioplasty plate.
§ 882.5330Preformed nonalterable cranioplasty plate.
§ 882.5360Cranioplasty plate fastener.
§ 882.5500Lesion temperature monitor.
§ 882.5550Central nervous system fluid shunt and components.
§ 882.5560Cerebrospinal fluid shunt system.
§ 882.5600Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
§ 882.5700Thermal system for insomnia.
§ 882.5705Digital therapy device to reduce sleep disturbance for psychiatric conditions.
§ 882.5800Cranial electrotherapy stimulator.
§ 882.5801Computerized behavioral therapy device for psychiatric disorders.
§ 882.5802Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
§ 882.5803Digital therapy device for Attention Deficit Hyperactivity Disorder.
§ 882.5805Repetitive transcranial magnetic stimulation system.
§ 882.5808Transcranial magnetic stimulator for headache.
§ 882.5810External functional neuromuscular stimulator.
§ 882.5820Implanted cerebellar stimulator.
§ 882.5830Implanted diaphragmatic/phrenic nerve stimulator.
§ 882.5840Implanted intracerebral/subcortical stimulator for pain relief.
§ 882.5850Implanted spinal cord stimulator for bladder evacuation.
§ 882.5855Brain stimulation programming planning software.
§ 882.5860Implanted neuromuscular stimulator.
§ 882.5870Implanted peripheral nerve stimulator for pain relief.
§ 882.5880Implanted spinal cord stimulator for pain relief.
§ 882.5889Electrical tongue nerve stimulator to treat motor deficits.
§ 882.5890Transcutaneous electrical nerve stimulator for pain relief.
§ 882.5891Transcutaneous electrical nerve stimulator to treat headache.
§ 882.5892External vagal nerve stimulator for headache.
§ 882.5893Thermal vestibular stimulator for headache.
§ 882.5894Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
§ 882.5895Vibratory counter-stimulation device.
§ 882.5896Percutaneous nerve stimulator for substance use disorders.
§ 882.5897External upper limb tremor stimulator.
§ 882.5898Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
§ 882.5899Trunk and limb electrical stimulator to treat headache.
§ 882.5900Preformed craniosynostosis strip.
§ 882.5910Dura substitute.
§ 882.5940Electroconvulsive therapy device.
§ 882.5950Neurovascular embolization device.
§ 882.5955Temporary coil embolization assist device.
§ 882.5960Skull tongs for traction.
§ 882.5970Cranial orthosis.