Title 21, Part 882 — Neurological Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Rigidity analyzer.

Ataxiagraph.

Two-point discriminator.

Echoencephalograph.

Electroconductive media.

Cortical electrode.

Cutaneous electrode.

Depth electrode.

Nasopharyngeal electrode.

Needle electrode.

Electroencephalograph.

Electroencephalograph electrode/lead tester.

Electroencephalogram (EEG) signal spectrum analyzer.

Electroencephalograph test signal generator.

Neuropsychiatric interpretive electroencephalograph assessment aid.

Brain injury adjunctive interpretive electroencephalograph assessment aid.

Traumatic brain injury eye movement assessment aid.

Nystagmograph.

Computerized cognitive assessment aid.

Computerized cognitive assessment aid for concussion.

Neurological endoscope.

Pediatric Autism Spectrum Disorder diagnosis aid.

Esthesiometer.

Tuning fork.

Galvanic skin response measurement device.

Nerve conduction velocity measurement device.

Skin potential measurement device.

Evoked photon image capture device.

Powered direct-contact temperature measurement device.

Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.

Alpha monitor.

Intracranial pressure monitoring device.

Cranial motion measurement device.

Percussor.

Pinwheel.

Ocular plethysmograph.

Rheoencephalograph.

Physiological signal amplifier.

Physiological signal conditioner.

Electroencephalogram (EEG) telemetry system.

Evoked response electrical stimulator.

Evoked response mechanical stimulator.

Evoked response photic stimulator.

Evoked response auditory stimulator.

Ultrasonic scanner calibration test block.

Near Infrared (NIR) Brain Hematoma Detector.

Tremor transducer.

Skull plate anvil.

Ventricular cannula.

Ventricular catheter.

Neurosurgical chair.

Scalp clip.

Aneurysm clip applier.

Clip forming/cutting instrument.

Clip removal instrument.

Clip rack.

Cryogenic surgical device.

Dowel cutting instrument.

Manual cranial drills, burrs, trephines, and their accessories

Powered compound cranial drills, burrs, trephines, and their accessories.

Powered simple cranial drills, burrs, trephines, and their accessories.

Cranial drill handpiece (brace).

Electric cranial drill motor.

Pneumatic cranial drill motor.

Radiofrequency lesion generator.

Neurosurgical headrests.

Neurosurgical head holder (skull clamp).

Cranioplasty material forming instrument.

Microsurgical instrument.

Nonpowered neurosurgical instrument.

Shunt system implantation instrument.

Stereotaxic instrument.

Field generator positioning device.

Leukotome.

Neurosurgical suture needle.

Neurosurgical paddie.

Radiofrequency lesion probe.

Skull punch.

Self-retaining retractor for neurosurgery.

Manual rongeur.

Powered rongeur.

Skullplate screwdriver.

Diagnostic neurosurgical microscope filter.

Methyl methacrylate for aneurysmorrhaphy.

Biofeedback device.

Conditioning tool for eating disorders.

Bite block.

Intravascular occluding catheter.

Carotid artery clamp.

Aneurysm clip.

Implanted malleable clip.

Aversive conditioning device.

Burr hole cover.

Nerve cuff.

Methyl methacrylate for cranioplasty.

Preformed alterable cranioplasty plate.

Preformed nonalterable cranioplasty plate.

Cranioplasty plate fastener.

Lesion temperature monitor.

Central nervous system fluid shunt and components.

Cerebrospinal fluid shunt system.

Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.

Thermal system for insomnia.

Digital therapy device to reduce sleep disturbance for psychiatric conditions.

Cranial electrotherapy stimulator.

Computerized behavioral therapy device for psychiatric disorders.

Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.

Digital therapy device for Attention Deficit Hyperactivity Disorder.

Repetitive transcranial magnetic stimulation system.

Transcranial magnetic stimulator for headache.

External functional neuromuscular stimulator.

Implanted cerebellar stimulator.

Implanted diaphragmatic/phrenic nerve stimulator.

Implanted intracerebral/subcortical stimulator for pain relief.

Implanted spinal cord stimulator for bladder evacuation.

Brain stimulation programming planning software.

Implanted neuromuscular stimulator.

Implanted peripheral nerve stimulator for pain relief.

Implanted spinal cord stimulator for pain relief.

Electrical tongue nerve stimulator to treat motor deficits.

Transcutaneous electrical nerve stimulator for pain relief.

Transcutaneous electrical nerve stimulator to treat headache.

External vagal nerve stimulator for headache.

Thermal vestibular stimulator for headache.

Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.

Vibratory counter-stimulation device.

Percutaneous nerve stimulator for substance use disorders.

External upper limb tremor stimulator.

Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.

Trunk and limb electrical stimulator to treat headache.

Preformed craniosynostosis strip.

Dura substitute.

Electroconvulsive therapy device.

Neurovascular embolization device.

Temporary coil embolization assist device.

Skull tongs for traction.

Cranial orthosis.