• 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 transcranial magnetic stimulation system for obsessive-compulsive disorder
Regulation Description Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Definition External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).
Product CodeQCI
Regulation Number 882.5802
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINSWAY LTD.
  SUBSTANTIALLY EQUIVALENT 1


-
-