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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneous nerve stimulator for opioid withdrawal
Regulation Description Percutaneous nerve stimulator for substance use disorders.
Definition Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
Product CodePZR
Regulation Number 882.5896
Device Class 2


Premarket Reviews
ManufacturerDecision
DYANSYS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NET RECOVERY
  SUBSTANTIALLY EQUIVALENT 1
SPARK BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

Recalls
Manufacturer Recall Class Date Posted
1 Spark Biomedical Inc II Aug-11-2025
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