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U.S. Department of Health and Human Services

Product Classification

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Device vibratory counter-stimulation
Definition A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary restless legs syndrome.
Physical State vibrating pad
Technical Method Applies a mechanical vibration to the lower legs
Target Area Lower legs
Regulation Medical Specialty Neurology
Review Panel Physical Medicine
Product CodeOVP
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 882.5895
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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