TPLC - Total Product Life Cycle

• Device: perineometer
• Product Code: HIR
• Regulation Number: 884.1425
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADVANCED TACTILE IMAGING INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED TACTILE IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANALYTICA LTD
	SUBSTANTIALLY EQUIVALENT	1
ANALYTICA LTD.
	SUBSTANTIALLY EQUIVALENT	1
APIMEDS, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOINFINITY (M) SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
BIOINFINITY (M)SDN.BHD.
	SUBSTANTIALLY EQUIVALENT	1
KAMABRY, INC., DBA INNER PEACE FOR WOMEN
	SUBSTANTIALLY EQUIVALENT	1
ORELLE CORPORATION LTD
	SUBSTANTIALLY EQUIVALENT	1
PELVITAL USA, INC.
	SUBSTANTIALLY EQUIVALENT	4
PLUS EV HOLDINGS DBA INTIMATE ROSE
	SUBSTANTIALLY EQUIVALENT	1
RALSTON GROUP
	SUBSTANTIALLY EQUIVALENT	1
REGULATORY INSIGHT, INC.
	SUBSTANTIALLY EQUIVALENT	1
REMENDIUM LABS, LLC
	SUBSTANTIALLY EQUIVALENT	1
RENOVIA INC.
	SUBSTANTIALLY EQUIVALENT	4
X6 INNOVATIONS
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2024	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Abdominal Cramps	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ralston Group	II	Jul-26-2019