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U.S. Department of Health and Human Services

Product Classification

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Device dynamometer, ac-powered
Regulation Description AC-powered dynamometer.
Regulation Medical Specialty Orthopedic
Review Panel Neurology
Product CodeLBB
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
Submission Type 510(k)
Regulation Number 888.1240
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons

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