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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device perineometer
Regulation Description Perineometer.
Product CodeHIR
Regulation Number 884.1425
Device Class 2


Premarket Reviews
ManufacturerDecision
ANALYTICA LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOINFINITY (M) SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
PELVITAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
PLUS EV HOLDINGS DBA INTIMATE ROSE
  SUBSTANTIALLY EQUIVALENT 1
RALSTON GROUP
  SUBSTANTIALLY EQUIVALENT 1
RENOVIA INC.
  SUBSTANTIALLY EQUIVALENT 3

Recalls
Manufacturer Recall Class Date Posted
1 Ralston Group II Jul-26-2019
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