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 upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography
Definition Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality.
Product CodePAE
Regulation Number 890.3450
Device Class 2

MDR Year MDR Reports MDR Events
2018 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Fracture 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 3 3
Fracture, Arm 1 1

-
-