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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Product CodeLPQ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 1 0 1 0 4 1 0 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Output above Specifications 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1 1
Shock 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew Inc II Aug-04-2009
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