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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transmitters and receivers, physiological signal, radiofrequency
Regulation Description Radiofrequency physiological signal transmitter and receiver.
Product CodeDRG
Regulation Number 870.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
ALIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOINTELLISENSE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOLNTELLISENSE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOLINE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ELASTIC CARE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ERGOLINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
GRAFTWORX, INC. DBA ALIO
  SUBSTANTIALLY EQUIVALENT 1
INGENIARS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
IORBIT DIGITAL TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LIFESIGNALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PERIN HEALTH DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIBEL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIBEL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIGKNOW BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE SCOTTCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VIVIFY HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Biointellisense Inc. II Aug-14-2024
2 Nihon Kohden America Inc II Mar-02-2021
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