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
Regulation Description Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.
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

-
-