TPLC - Total Product Life Cycle

• Device: massager, powered inflatable tube
• Regulation Description: Powered inflatable tube massager.
• Product Code: IRP
• Regulation Number: 890.5650
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AQUILO SPORTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
AVANOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIO COMPRESSION SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
DAESUNG MAREF CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
DIODE ART ENGINEERING DOING BUSINESS AS AIR RELAX
	SUBSTANTIALLY EQUIVALENT	2
ELASTIMED , LTD.
	SUBSTANTIALLY EQUIVALENT	1
EVA MEDTEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
FIST ASSIST DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
FOGGIARE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN HONGFENG CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU LONGEST MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUIZHOU XINYI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
JIALE HEALTH TECHNOLOGY SHENZHEN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU MAXF ELECTRIC APPLIANCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JKH HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
KONLIKING TECH & DEV. LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MAXSTAR INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDELLA HEALTH LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MEGO AFEK
	SUBSTANTIALLY EQUIVALENT	1
MERCHSOURCE, LLC
	SUBSTANTIALLY EQUIVALENT	1
MKS PARIS
	SUBSTANTIALLY EQUIVALENT	1
NORMATEC INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	4
SHENZHEN DONGJILIAN MEDICAL TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN FUTURE ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN RUIYI BUSINESS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN URION TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN XINRUN ELECTRIC APPLIANCES CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YICAI HEALTH TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN QIANII-BEOKA MEDICAL TECHNOIOGY LNC.
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN QIANLI-BEOKA MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
SLK MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU MICROPORT REHABTECH (GROUP) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THERABODY, INC.
	SUBSTANTIALLY EQUIVALENT	1
THERAGUN, INC.
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU LINGFENG ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WONJIN MULSAN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
XIAMEN EMOKA HEALTH SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN HEALTHPAL ELECTRONIC CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN HIGH TOP ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN SIMO ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN TAOTAO TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN WEIYOU INTELLIGENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
ZAMAR MEDICAL D.O.O.
	SUBSTANTIALLY EQUIVALENT	1
ZENITH TECHNICAL INNOVATIONS
	SUBSTANTIALLY EQUIVALENT	1
ZHANGZHOU EASEPAL INNOVATION CO , LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2022	1	2
2024	4	4
2025	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Battery Problem	8	8
Adverse Event Without Identified Device or Use Problem	2	2
Electrical /Electronic Property Problem	2	2
Inadequate Instructions for Non-Healthcare Professional	1	1
Material Rupture	1	2
Product Quality Problem	1	2
Explosion	1	1
Increase in Pressure	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10	10
Pain	3	4
Cramp(s) /Muscle Spasm(s)	1	1
Rash	1	1
Neck Pain	1	1
Erythema	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Compass Health Brands (Corporate Office)	II	Apr-18-2023
2	Zhejiang Luyao Electronics Technology Co., Ltd.	II	Aug-28-2025