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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device exerciser, non-measuring
Product CodeION
Regulation Number 890.5370
Device Class 1


Premarket Reviews
ManufacturerDecision
IM-ABLE LTD
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Amtryke LLC II Apr-24-2015
2 North Coast Medical Inc II May-14-2012
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