Federal (United States) · Regulations
Subpart F — Neurological Therapeutic Devices
54 sections
54 sections
- 21 C.F.R. § 882.5030Methyl methacrylate for aneurysmorrhaphy.
- 21 C.F.R. § 882.5050Biofeedback device.
- 21 C.F.R. § 882.5060Conditioning tool for eating disorders.
- 21 C.F.R. § 882.5070Bite block.
- 21 C.F.R. § 882.5150Intravascular occluding catheter.
- 21 C.F.R. § 882.5175Carotid artery clamp.
- 21 C.F.R. § 882.5200Aneurysm clip.
- 21 C.F.R. § 882.5225Implanted malleable clip.
- 21 C.F.R. § 882.5235Aversive conditioning device.
- 21 C.F.R. § 882.5250Burr hole cover.
- 21 C.F.R. § 882.5275Nerve cuff.
- 21 C.F.R. § 882.5300Methyl methacrylate for cranioplasty.
- 21 C.F.R. § 882.5320Preformed alterable cranioplasty plate.
- 21 C.F.R. § 882.5330Preformed nonalterable cranioplasty plate.
- 21 C.F.R. § 882.5360Cranioplasty plate fastener.
- 21 C.F.R. § 882.5500Lesion temperature monitor.
- 21 C.F.R. § 882.5550Central nervous system fluid shunt and components.
- 21 C.F.R. § 882.5560Cerebrospinal fluid shunt system.
- 21 C.F.R. § 882.5600Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
- 21 C.F.R. § 882.5700Thermal system for insomnia.
- 21 C.F.R. § 882.5705Digital therapy device to reduce sleep disturbance for psychiatric conditions.
- 21 C.F.R. § 882.5800Cranial electrotherapy stimulator.
- 21 C.F.R. § 882.5801Computerized behavioral therapy device for psychiatric disorders.
- 21 C.F.R. § 882.5802Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
- 21 C.F.R. § 882.5803Digital therapy device for Attention Deficit Hyperactivity Disorder.
- 21 C.F.R. § 882.5805Repetitive transcranial magnetic stimulation system.
- 21 C.F.R. § 882.5808Transcranial magnetic stimulator for headache.
- 21 C.F.R. § 882.5810External functional neuromuscular stimulator.
- 21 C.F.R. § 882.5820Implanted cerebellar stimulator.
- 21 C.F.R. § 882.5830Implanted diaphragmatic/phrenic nerve stimulator.
- 21 C.F.R. § 882.5840Implanted intracerebral/subcortical stimulator for pain relief.
- 21 C.F.R. § 882.5850Implanted spinal cord stimulator for bladder evacuation.
- 21 C.F.R. § 882.5855Brain stimulation programming planning software.
- 21 C.F.R. § 882.5860Implanted neuromuscular stimulator.
- 21 C.F.R. § 882.5870Implanted peripheral nerve stimulator for pain relief.
- 21 C.F.R. § 882.5880Implanted spinal cord stimulator for pain relief.
- 21 C.F.R. § 882.5889Electrical tongue nerve stimulator to treat motor deficits.
- 21 C.F.R. § 882.5890Transcutaneous electrical nerve stimulator for pain relief.
- 21 C.F.R. § 882.5891Transcutaneous electrical nerve stimulator to treat headache.
- 21 C.F.R. § 882.5892External vagal nerve stimulator for headache.
- 21 C.F.R. § 882.5893Thermal vestibular stimulator for headache.
- 21 C.F.R. § 882.5894Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
- 21 C.F.R. § 882.5895Vibratory counter-stimulation device.
- 21 C.F.R. § 882.5896Percutaneous nerve stimulator for substance use disorders.
- 21 C.F.R. § 882.5897External upper limb tremor stimulator.
- 21 C.F.R. § 882.5898Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
- 21 C.F.R. § 882.5899Trunk and limb electrical stimulator to treat headache.
- 21 C.F.R. § 882.5900Preformed craniosynostosis strip.
- 21 C.F.R. § 882.5910Dura substitute.
- 21 C.F.R. § 882.5940Electroconvulsive therapy device.
- 21 C.F.R. § 882.5950Neurovascular embolization device.
- 21 C.F.R. § 882.5955Temporary coil embolization assist device.
- 21 C.F.R. § 882.5960Skull tongs for traction.
- 21 C.F.R. § 882.5970Cranial orthosis.