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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device massager, powered inflatable tube
Product CodeIRP
Regulation Number 890.5650
Device Class 2


Premarket Reviews
ManufacturerDecision
AQUILO SPORTS LLC
  SUBSTANTIALLY EQUIVALENT 1
BIO COMPRESSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BREG INC.
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
COOL SYSTEMS, INC. (DBA GAME READY)
  SUBSTANTIALLY EQUIVALENT 2
DAESUNG MAREF CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
DAESUNG MAREF CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
DIODE ART ENGINEERING DOING BUSINESS AS AIR RELAX
  SUBSTANTIALLY EQUIVALENT 2
EVA MEDTEC, INC
  SUBSTANTIALLY EQUIVALENT 1
FIG, LLC
  SUBSTANTIALLY EQUIVALENT 1
FIST ASSIST DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOGGIARE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN HONGFENG CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN HONGFENG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANURI DISTRIBUTION, INC
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XINYI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU MAXF ELECTRIC APPLIANCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JKH HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
KONLIKING TECH & DEV. LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MANAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXSTAR INDUSTRIAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAXSTAR INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MAXSTAR INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDELLA HEALTH LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEGO AFEK
  SUBSTANTIALLY EQUIVALENT 1
MEGO AFEK AC LTD
  SUBSTANTIALLY EQUIVALENT 2
MEGO AFEK AC LTD.
  SUBSTANTIALLY EQUIVALENT 4
MENLO BRANDS LLC
  SUBSTANTIALLY EQUIVALENT 1
MKS PARIS
  SUBSTANTIALLY EQUIVALENT 1
NICE RECOVERY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NORMATEC INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 6
PORTABLE THERAPEUTIX
  SUBSTANTIALLY EQUIVALENT 1
PORTABLE THERAPEUTIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
RAPID REBOOT RECOVERY PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DONGJILIAN ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DONGJILIAN MEDICAL TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN FUTURE ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN RUIYI BUSINESS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLK MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MICROPORT REHABTECH (GROUP) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE AMERICAN EXPORT GROUP & INTERNATIONAL SERVICES
  SUBSTANTIALLY EQUIVALENT 1
THERAGUN, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIASONIX LTD.
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU LINGFENG ELECTRONIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WON INDUSTRIAL CO.
  SUBSTANTIALLY EQUIVALENT 2
WONJIN MULSAN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WONJIN MULSAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
WONJINMULSAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 SENYANG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
XIAMEN SIMO ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN WEIYOU INTELLIGENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN WEIYOU INTELLIGENT TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ZENITH TECHNICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 4
ZHANGZHOU EASEPAL INNOVATION CO LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 2 2
2020 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Auto Stop 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Increase in Pressure 1 1
Product Quality Problem 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Injury 2 2
Swelling 1 1
Wound Dehiscence 1 1
Death 1 1
Dyspnea 1 1
Edema 1 1
Hematoma 1 1
Neuropathy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Compass Health Brands (Corporate Office) II Apr-18-2023
2 CoolSystems, Inc. III Sep-14-2011
3 Won Industry Co. II Dec-06-2017
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