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U.S. Department of Health and Human Services

Product Classification

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Device stroller, adaptive
Regulation Description Mechanical wheelchair.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeLBE
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 890.3850
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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