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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator,peripheral nerve,non-implanted,for pelvic floor dysfunction
Regulation Description Nonimplanted, peripheral electrical continence device.
Product CodeNAM
Regulation Number 876.5310
Device Class 2

Device Problems
No Known Device Problem 15
Failure to deliver energy 1
Malposition of device 1
Device operates differently than expected 1
Foreign material present in device 1
Material deformation 1
Total Device Problems 20

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