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- MiscellaneousMiscellaneous
- LEMHuman Lyophilized Dura Mater2Product Code
- LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief3Product Code
- LHYElectrode, Stabilized Epidural Spinal3Product Code
- LIIMonitor, Intracranial Pressure, Implanted3Product Code
- LKWLaser, Neurosurgical3Product Code
- LLEStimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease3Product Code
- LLFLaser, Neurosurgical, Argon3Product Code
- LLPLaser For Pain Therapy3Product Code
- LMEMonitor, Blood-Flow, Cerebral, Thermal Diffusion3Product Code
- LQDRecorder, Attention Task PerformanceUProduct Code
- LYIStimulator, Subcortical, Implanted For Epilepsy3Product Code
- LYJStimulator, Autonomic Nerve, Implanted For Epilepsy3Product Code
- MBXStimulator, Thalamic, Epilepsy, Implanted3Product Code
- BWKStimulator, Electro-AcupunctureUProduct Code
- KGFAdhesive, Tissue For Aneurysmorrhaphy3Product Code
- KGGTissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations3Product Code
- LBKDevice, Neurosurgical Fragmentation And AspirationUProduct Code
- MFEAgent, Injectable, Embolic3Product Code
- MFRStimulator, Brain, Implanted, For Behavior ModificationFProduct Code
- MHYStimulator, Electrical, Implanted, For Parkinsonian Tremor3Product Code
- MHZStimulator, Vestibular Acceleration, Therapeutic3Product Code
- MKDStimulator, Functional Walking Neuromuscular, Non-Invasive3Product Code
- MLQInhibitor, Peridural Fibrosis (Adhesion Barrier)3Product Code
- MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)FProduct Code
- MUZStimulator, Autonomic Nerve, Implanted (Depression)3Product Code
- MVVDevice, AcupressureUProduct Code
- MXMCap, Cooling (Infants)3Product Code
- NHLStimulator, Electrical, Implanted, For Parkinsonian Symptoms3Product Code
- NJEIntracranial Neurovascular StentFProduct Code
- NPEMaterial, Embolization, Neurovascular, Polymerizing Or Precipitating3Product Code
- NQRSealant, Dural3Product Code
- NZKStimulator, Low Electric Field, Tumor Treatment3Product Code
- OBAPolymerizing, Neurovascular Embolization MaterialFProduct Code
- OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)FProduct Code
- OPRIntrasaccular Flow Disruption Device3Product Code
- OUTIntracranial Aneurysm Flow Diverter3Product Code
- OUUPolymeric Neurovascular EmbolizationFProduct Code
- OVCHeadframeNProduct Code
- OZJInhibitor, Postoperative Fibrosis (Adhesion Barrier)NProduct Code
- PAXSurgical KitFProduct Code
- PCQInhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)NProduct Code
- PFNImplanted Brain Stimulator For Epilepsy3Product Code
- PJSStimulator, Electrical, Implanted, For Essential Tremor3Product Code
- PMPDorsal Root Ganglion Stimulator For Pain Relief3Product Code
- POHMr-Guided Focused Ultrasound System3Product Code
- QCAIntracranial Coil-Assist Stent3Product Code
- QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief3Product Code
- QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy3Product Code
- QSLBrain Temperature Measurement System2Product Code
- QSQTranscutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms2Product Code
- QWDStimulator, Nerve, For Restless Legs Syndrome2Product Code
- QTKTemporary Percutaneous Transluminal Cerebral Artery Dilatation DeviceFProduct Code
- SAZStimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb3Product Code
- QWTPrognostic Assessment Software Of Mild Cognitive Impairment2Product Code
- SBGIn Situ Polymerizing Peripheral Nerve Cap2Product Code
- SDGBrain Intraparenchymal Infusion Cannula2Product Code
- SDXNeuromuscular Stimulator And Exercise Evaluation System2Product Code
- SEEComputerized Behavioral Therapy Device For Migraine2Product Code
- SEMSub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring2Product Code
- SFDIn Situ Polymerizing Peripheral Nerve Repair Device2Product Code
- SFNNon-Invasive Evoked Response Brain Stimulator2Product Code
- SFJVagus Nerve Stimulator For Rheumatoid Arthritis3Product Code
- SGBPain Assessment Software In Non-Communicative Adults2Product Code
- SGNHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation2Product Code
- SGSDeep Brain Stimulation For The Treatment Of Dystonia3Product Code
- SGUNeurovascular Liquid Embolic Agent3Product Code
- SGFDural Arteriovenous Fistula Liquid EmbolicFProduct Code
- Submissions with No Product CodeMiscellaneous
- 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
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Pain Assessment Software In Non-Communicative Adults
- Page Type
- Product Code
- Definition
- Pain assessment software in non-communicative adults is a prescription-only device that combines information from clinical pain domains to produce an output indicative of a patient’s current level of pain in conscious adult patients who are unable to communicate their current pain level. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool.
- Physical State
- Contains recording hardware (e.g., video camera) and Software (e.g., used to process, analyze, display, store, or archive data).
- Technical Method
- A device that uses facial recognition to detect facial features indicative of the presence of pain
- Target Area
- Face
- Regulation Medical Specialty
- Neurology
- Review Panel
- Neurology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 882.1472
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code SGB is linked to regulation 21CFR882.1472, which does not seem to exist yet. It may be pending at the moment.