TPLC - Total Product Life Cycle

• Device: needle, acupuncture, single use
• Product Code: MQX
• Regulation Number: 880.5580
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ASIA-MED GMBH AND CO KG
	SUBSTANTIALLY EQUIVALENT	1
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGCHUN AIK MEDICAL DEVICES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HAENGLIM SEOWON MEDICAL CO.
	SUBSTANTIALLY EQUIVALENT	1
HANSOL MEDICAL CO.
	SUBSTANTIALLY EQUIVALENT	1
K.M.S. INC.
	SUBSTANTIALLY EQUIVALENT	1
K.S. CHOI CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMC INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
WOOJEON COMPANY
	SUBSTANTIALLY EQUIVALENT	1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	1	1
2016	1	1
2018	1	1
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1	1
Difficult to Remove	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Device	1	1
Detachment of Device or Device Component	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	1	1
Pneumothorax	1	1
Needle Stick/Puncture	1	1
Burn, Thermal	1	1
No Known Impact Or Consequence To Patient	1	1
No Code Available	1	1