Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device table, physical therapy, multi function
Product CodeJFB
Regulation Number 890.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
ACQPOINT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CERAGEM CO, LTD.
  SUBSTANTIALLY EQUIVALENT 3
CERAGEM INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CHOYANG MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INAREX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MT TABLES, LLC
  SUBSTANTIALLY EQUIVALENT 1
NUGA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
PNEUMEX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 3 3
Crack 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

-
-