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
- QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- SCPComputerized Behavioral Therapy Device For Anxiety Disorders2Product 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
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- Medical GeneticsReview Panel
- UnknownReview Panel
Eating Disorder Conditioning Tool
- Page Type
- Product Code
- Definition
- A conditioning tool for eating disorders is a medical device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.
- Physical State
- A flat scale is connected to a monitor which records data and displays the food consumption rate. The monitor also prompts the user for satiety sensation and displays trend.
- Technical Method
- Uses scale to meaure weight of plate during meal. Prompts user to provide feedback on satiety during meal. Provides display for actual and target food consumption rate.
- Target Area
- brain and stomach
- Regulation Medical Specialty
- Neurology
- Review Panel
- Neurology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 882.5060
- 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 § 882.5060 Conditioning tool for eating disorders
§ 882.5060 Conditioning tool for eating disorders.
(a) Identification. A conditioning tool for eating disorders is a prescription device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Nonclinical performance testing must demonstrate:
(i) Device measurement accuracy and repeatability; and
(ii) Device feedback accuracy.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.
(5) Labeling and patient labeling must be provided which includes the following:
(i) Information identifying and explaining how to use the device and its components; and
(ii) Information on how the device operates and the typical course of treatment.
[86 FR 68403, Dec. 2, 2021]