Part 882 Subpart F—Neurological Therapeutic Devices
FDA submissions for Part 882 Subpart F—Neurological Therapeutic Devices in the Neurology (NE) review panel, including product codes and regulations.
Section range: §§ 882.5030–882.5975
CFR Part: 882
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| JXH | Methyl Methacrylate For Aneurysmorrhaphy | 882.5030 | 2 | 3 |
| HCC | Device, Biofeedback | 882.5050 | 2 | 172 |
| LEL | Device, Sleep Assessment | 882.5050 | 2 | 19 |
| SEN | Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety | 882.5050 | 2 | 1 |
| OBV | Eating Disorder Conditioning Tool | 882.5060 | 2 | 1 |
| JXL | Block, Bite | 882.5070 | 2 | 28 |
| HBZ | Catheter, Intravascular Occluding | 882.5150 | 3 | 0 |
| NUF | Catheter, Neurovasculature, Occluding Balloon | 882.5150 | 3 | 0 |
| PAV | Catheter, Neuro-Vasculature, Occluding Balloon | 882.5150 | f | 0 |
| HCE | Clamp, Carotid Artery | 882.5175 | 2 | 2 |
| HCH | Clip, Aneurysm | 882.5200 | 2 | 36 |
| HBP | Clip, Implanted Malleable | 882.5225 | 2 | 0 |
| HCB | Device, Aversive Conditioning | 882.5235 | 2 | 6 |
| GXR | Cover, Burr Hole | 882.5250 | 2 | 29 |
| SBG | In Situ Polymerizing Peripheral Nerve Cap | 882.5260 | 2 | 2 |
| SFD | In Situ Polymerizing Peripheral Nerve Repair Device | 882.5270 | 2 | 2 |
| JXI | Cuff, Nerve | 882.5275 | 2 | 40 |
| GXP | Methyl Methacrylate For Cranioplasty | 882.5300 | 2 | 43 |
| MYU | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty | 882.5300 | 2 | 6 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 882.5320 | 2 | 42 |
| PJM | Filler, Bone Void, Alterable Compound For Cranioplasty | 882.5320 | 2 | 0 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 882.5330 | 2 | 55 |
| PBJ | Cranial Distraction System | 882.5330 | 2 | 6 |
| PJN | Filler, Bone Void, Non-Alterable Compound For Cranioplasty | 882.5330 | 2 | 2 |
| HBW | Fastener, Plate, Cranioplasty | 882.5360 | 2 | 7 |
| GXT | Monitor, Lesion Temperature | 882.5500 | 2 | 0 |
| JXG | Shunt, Central Nervous System And Components | 882.5550 | 2 | 258 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | 882.5550 | 2 | 8 |
| PVL | Endoscopic Shunt Placement Kit | 882.5550 | 2 | 0 |
| PVO | Lumbar Drainage Catheter Kit | 882.5550 | 2 | 0 |
| PCB | External Cerebrospinal Fluid (Csf) Diversion | 882.5560 | 2 | 2 |
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | 882.5600 | 2 | 18 |
| PLU | Thermal System For Insomnia | 882.5700 | 2 | 1 |
| QMZ | Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions | 882.5705 | 2 | 1 |
| JXK | Cranial Electrotherapy Stimulator To Treat Depression | 882.5800 | 3 | 2 |
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | 882.5800 | 2 | 19 |
| PWE | Computerized Behavioral Therapy Device For Substance Use Disorders | 882.5801 | 2 | 2 |
| QVO | Computerized Behavioral Therapy Device For Insomnia | 882.5801 | 2 | 2 |
| SAP | Computerized Behavioral Therapy Device For Depressive Disorders. | 882.5801 | 2 | 2 |
| SCP | Computerized Behavioral Therapy Device For Anxiety Disorders | 882.5801 | 2 | 1 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | 882.5802 | 2 | 9 |
| QMD | Transcranial Magnetic Stimulation System For Smoking Cessation | 882.5802 | 2 | 2 |
| QWI | Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms | 882.5804 | 2 | 1 |
| OBP | Transcranial Magnetic Stimulator | 882.5805 | 2 | 64 |
| QFF | Electromechanical Arm For A Transcranial Magnetic Stimulation System | 882.5805 | 2 | 1 |
| SEE | Computerized Behavioral Therapy Device For Migraine | 882.5806 | 2 | 1 |
| OKP | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache | 882.5808 | 2 | 6 |
| GZI | Stimulator, Neuromuscular, External Functional | 882.5810 | 2 | 61 |
| GZA | Implanted Cerebellar Stimulator | 882.5820 | 3 | 0 |
| GZE | Implanted Diaphragmatic/Phrenic Nerve Stimulator | 882.5830 | 3 | 1 |
| GYZ | Stimulator, Intracerebral/Subcortical, Implanted | 882.5840 | 3 | 0 |
| GZD | Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation | 882.5850 | 3 | 0 |
| QQC | Brain Stimulation Programming Planning Software. | 882.5855 | 2 | 3 |
| GZC | Stimulator, Neuromuscular, Implanted | 882.5860 | 3 | 1 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 882.5870 | 2 | 25 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 882.5880 | 2 | 139 |
| LHG | Electrode, Spinal Epidural | 882.5880 | 2 | 1 |
| QWD | Stimulator, Nerve, For Restless Legs Syndrome | 882.5887 | 2 | 1 |
| QSQ | Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms | 882.5888 | 2 | 1 |
| QCF | Electrical Tongue Stimulator To Treat Motor Deficits | 882.5889 | 2 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 882.5890 | 2 | 605 |
| LIH | Interferential Current Therapy | 882.5890 | 2 | 73 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 882.5890 | 2 | 75 |
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | 882.5890 | 2 | 13 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 882.5890 | 2 | 227 |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | 882.5890 | 2 | 8 |
| NYW | Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief | 882.5890 | 2 | 0 |
| NYX | Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes | 882.5890 | 2 | 0 |
| OCF | Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief | 882.5890 | 2 | 1 |
| QFD | Tens For Sinus Pain | 882.5890 | 2 | 0 |
| QPL | Electromagnetic Stimulator, Pain Relief | 882.5890 | 2 | 6 |
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 882.5891 | 2 | 18 |
| PKR | Non-Invasive Vagus Nerve Stimulator - Headache | 882.5892 | 2 | 9 |
| QAK | Non-Invasive Vagus Nerve Stimulator For Migraine Headache | 882.5892 | 2 | 0 |
| QAR | Thermal Vestibular Stimulator For Headache | 882.5893 | 2 | 1 |
| OSG | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | 882.5894 | 2 | 2 |
| PZR | Percutaneous Nerve Stimulator For Opioid Withdrawal | 882.5896 | 2 | 8 |
| QBC | External Upper Limb Tremor Stimulator | 882.5897 | 2 | 9 |
| QGL | Transcutaneous Nerve Stimulator For Adhd | 882.5898 | 2 | 5 |
| QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | 882.5899 | 2 | 7 |
| GXO | Strip, Craniosynostosis, Preformed | 882.5900 | 2 | 2 |
| GXQ | Dura Substitute | 882.5910 | 2 | 43 |
| GXC | Device, Electroconvulsive Therapy | 882.5940 | 3 | 0 |
| QGH | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder | 882.5940 | 2 | 9 |
| HCG | Device, Neurovascular Embolization | 882.5950 | 2 | 184 |
| MZQ | Balloon, Detachable, For Neurovascular Occlusion | 882.5950 | 2 | 2 |
| PUU | Temporary Coil Embolization Assist Device | 882.5955 | 2 | 1 |
| HAX | Tong, Skull For Traction | 882.5960 | 2 | 20 |
| MVA | Orthosis, Cranial | 882.5970 | 2 | 43 |
| OAN | Orthosis, Cranial, Laser Scan | 882.5970 | 2 | 23 |
| LEM | Human Lyophilized Dura Mater | 882.5975 | 2 | 2 |
