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U.S. Department of Health and Human Services

Product Classification

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Device foot wrap for treating restless leg syndrome symptoms
Definition Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.
Physical State Compressive wrap.
Technical Method Applies pressure to the abductor hallucis and abductor hallucis brevis adequate to affect the peripheral nervous system.
Target Area Abductor hallucis and abductor hallucis brevis muscles.
Regulation Medical Specialty Physical Medicine
Review Panel Neurology
Product CodeOTX
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 890.5760
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible