21 CFR Subpart F - Subpart F—Neurological Therapeutic Devices

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  1. § 882.5030 Methyl methacrylate for aneurysmorrhaphy.
  2. § 882.5050 Biofeedback device.
  3. § 882.5060 Conditioning tool for eating disorders.
  4. § 882.5070 Bite block.
  5. § 882.5150 Intravascular occluding catheter.
  6. § 882.5175 Carotid artery clamp.
  7. § 882.5200 Aneurysm clip.
  8. § 882.5225 Implanted malleable clip.
  9. § 882.5235 Aversive conditioning device.
  10. § 882.5250 Burr hole cover.
  11. § 882.5275 Nerve cuff.
  12. § 882.5300 Methyl methacrylate for cranioplasty.
  13. § 882.5320 Preformed alterable cranioplasty plate.
  14. § 882.5330 Preformed nonalterable cranioplasty plate.
  15. § 882.5360 Cranioplasty plate fastener.
  16. § 882.5500 Lesion temperature monitor.
  17. § 882.5550 Central nervous system fluid shunt and components.
  18. § 882.5560 Cerebrospinal fluid shunt system.
  19. § 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
  20. § 882.5700 Thermal system for insomnia.
  21. § 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions.
  22. § 882.5800 Cranial electrotherapy stimulator.
  23. § 882.5801 Computerized behavioral therapy device for psychiatric disorders.
  24. § 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
  25. § 882.5805 Repetitive transcranial magnetic stimulation system.
  26. § 882.5808 Transcranial magnetic stimulator for headache.
  27. § 882.5810 External functional neuromuscular stimulator.
  28. § 882.5820 Implanted cerebellar stimulator.
  29. § 882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
  30. § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
  31. § 882.5850 Implanted spinal cord stimulator for bladder evacuation.
  32. § 882.5855 Brain stimulation programming planning software.
  33. § 882.5860 Implanted neuromuscular stimulator.
  34. § 882.5870 Implanted peripheral nerve stimulator for pain relief.
  35. § 882.5880 Implanted spinal cord stimulator for pain relief.
  36. § 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
  37. § 882.5891 Transcutaneous electrical nerve stimulator to treat headache.
  38. § 882.5892 External vagal nerve stimulator for headache.
  39. § 882.5893 Thermal vestibular stimulator for headache.
  40. § 882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
  41. § 882.5895 Vibratory counter-stimulation device.
  42. § 882.5896 Percutaneous nerve stimulator for substance use disorders.
  43. § 882.5897 External upper limb tremor stimulator.
  44. § 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
  45. § 882.5899 Trunk and limb electrical stimulator to treat headache.
  46. § 882.5900 Preformed craniosynostosis strip.
  47. § 882.5910 Dura substitute.
  48. § 882.5940 Electroconvulsive therapy device.
  49. § 882.5950 Neurovascular embolization device.
  50. § 882.5955 Temporary coil embolization assist device.
  51. § 882.5960 Skull tongs for traction.
  52. § 882.5970 Cranial orthosis.