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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device booth, sun tan
Regulation Description Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
Product CodeLEJ
Regulation Number 878.4635
Device Class 2


Premarket Reviews
ManufacturerDecision
BLV LICHT-UND VAKUUMTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
HEARTLAND TANNING, INC.
  SUBSTANTIALLY EQUIVALENT 1
IBL ACQUISITIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
J.W. HOLDING GMBH
  SUBSTANTIALLY EQUIVALENT 3
JK HOLDING GMBH
  SUBSTANTIALLY EQUIVALENT 2
KBL AG
  SUBSTANTIALLY EQUIVALENT 1
LIGHT SOURCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LPI, INC.
  SUBSTANTIALLY EQUIVALENT 1
PC MARKETING, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPORTARREDO GROUP S.C.
  SUBSTANTIALLY EQUIVALENT 2
SUN CAPSULE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SUNFIRE INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Electrical Overstress 8
Inadequate or Insufficient Training 1
Improper or Incorrect Procedure or Method 1
Fire 1
Electrical /Electronic Property Problem 1
Use of Device Problem 1
Total Device Problems 13

Recalls
Manufacturer Recall Class Date Posted
1 JK Products & Services, Inc II Sep-12-2014
2 ProSun International, LLC II Apr-16-2019
3 ProSun International, LLC II Jan-05-2018

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