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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spirometer, therapeutic (incentive)
Regulation Description Incentive spirometer.
Product CodeBWF
Regulation Number 868.5690
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED CIRCULATORY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
DHD HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
LEVENTON, S.A.
  SUBSTANTIALLY EQUIVALENT 2
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 2
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
STARKEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 22
Component(s), broken 21
Leak 11
Material separation 2
Occlusion within device 2
No Known Device Problem 1
Misassembled 1
Unknown (for use when the device problem is not known) 1
Data Issue 1
Device operates differently than expected 1
Air leak 1
Loose 1
Sticking 1
Break 1
Mechanical issue 1
Disconnection 1
Restricted flowrate 1
Device damaged prior to use 1
Total Device Problems 71

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