21 CFR Part 882 — Neurological Devices
Subpart A — General Provisions
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.
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.
- § 882.5803— 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.