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- MiscellaneousMiscellaneous
- LDKDevice, Sensing, Optical ContourUProduct Code
- LWBStimulator, Functional Neuromuscular, Scoliosis3Product Code
- LXMManipulator, Plunger-Like JointUProduct Code
- LZWMonitor, Spine CurvatureUProduct Code
- MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound Healing3Product Code
- MLYVapocoolant DeviceUProduct Code
- QPYStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation3Product Code
- QWIComputerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms2Product Code
- SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation2Product Code
- SECWearable Fall Injury Prevention Device2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
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Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
- Page Type
- Product Code
- Definition
- Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms
- Physical State
- Mobile medical application (MMA) intended to be accessed via a patient’s smartphone
- Technical Method
- Computerized Behavioral Therapy
- Target Area
- N/A
- Regulation Medical Specialty
- Neurology
- Review Panel
- Physical Medicine
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 882.5804
- 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 QWI is linked to regulation 21CFR882.5804, which does not seem to exist yet. It may be pending at the moment.