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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device generator, oxygen, portable
Regulation Description Portable oxygen generator.
Product CodeCAW
Regulation Number 868.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
3B MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BELLUSCURA, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAIRE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEVILBISS HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 2
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN KYCARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FOSHAN MIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HONSUN (NANTONG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INOGEN
  SUBSTANTIALLY EQUIVALENT 1
  1.  K222086  Inogen Rove 4 Portable Oxygen Concentrator
INOGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LONGFIAN SCITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MOLECULAR PRODUCTS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MV LIFE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANJING YINUOJI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIDEK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXYTEK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN HARVEYMED TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHENGZHOU OLIVE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 3B Medical, Inc. II Apr-15-2026
2 Caire, Inc. II Nov-15-2024
3 Caire, Inc. II May-19-2022
4 Caire, Inc. II Jan-13-2020
5 Caire, Inc. II Oct-30-2019
6 DeVilbiss Healthcare LLC II May-04-2023
7 DeVilbiss Healthcare LLC II Dec-19-2022
8 DeVilbiss Healthcare LLC II Nov-11-2022
9 Invacare Corporation III Jul-12-2022
10 Invacare Corporation II Dec-01-2020
11 JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD I Jan-03-2025
12 Medical Depot Inc. I May-09-2025
13 Ohio Medical Corporation II Jun-13-2025
14 Philips Respironics, Inc. II Nov-07-2025
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