• 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
Regulation Description Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components.
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


Premarket Reviews
ManufacturerDecision
DEKA INTEGRATED SOLUTIONS CORPORATION
  GRANTED 1

Device Problems
Insufficient Information 3
Migration or Expulsion of Device 2
Fracture 2
Unstable 1
Material Erosion 1
Total Device Problems 9


-
-