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 computerized behavioral therapy device for treating symptoms
Definition A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.
Product CodeQMY
Regulation Number 876.5960
Device Class 2


Premarket Reviews
ManufacturerDecision
MAHANA THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAHANA THERAPEUTICS, INC.
  GRANTED 1
METAME HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-