Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- MVAOrthosis, Cranial2Product Code
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Orthosis, Cranial, Laser Scan
- Page Type
- Product Code
- Definition
- A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
- Physical State
- Cranial orthotics are custom-made for each patient's head. They are typically made from plastics, foam and velcro.
- Technical Method
- A mold is made of the baby's head to create the orthotic. Plaster or laser scanning may be used to create the mold.
- Target Area
- Infant craniums
- Regulation Medical Specialty
- Neurology
- Review Panel
- Neurology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 882.5970
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 882.5970 Cranial orthosis
§ 882.5970 Cranial orthosis.
(a) Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
(b) Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).
[63 FR 40651, July 30, 1998]