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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ring, teething, fluid-filled
Product CodeKKO
Regulation Number 872.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIED HILL ENTERPRISES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEBE TOYS MANUFACTORY LTD.
  SUBSTANTIALLY EQUIVALENT 1
FU HONG INDUSTRIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
KIDS II
  SUBSTANTIALLY EQUIVALENT 2
LUV N' CARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAM INTERNATIONAL AG
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ELECTRONICS UK LIMITED
  SUBSTANTIALLY EQUIVALENT 1
QUALIMAN INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SOLID TOYS IND. LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILTEC INDUSTRIES LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Corroded 1 1
Crack 1 1
Device Emits Odor 1 1
Material Opacification 1 1
Component Missing 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
Choking 1 1

Recalls
Manufacturer Recall Class Date Posted
1 IMTEC Corporation II Sep-10-2009
2 Luv N' Care Ltd I Aug-12-2009
3 Tomy International Inc. II Dec-22-2022
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