DeviceClearance

Product code SAP— Neurology

MamaLift Plus

Classification name
Computerized Behavioral Therapy Device For Depressive Disorders.
Device class
Class 2
Regulation
21 CFR 882.5801
Advisory panel
Neurology
Total cleared
3
First cleared
Most recent

FDA classification definition

“The device is intended to provide computerized behavioral therapy to treat depressive disorders.”

— U.S. Food and Drug Administration, device classification record for product code SAP under 21 CFR 882.5801, via openFDA

Market context for product code SAP

FDA has cleared 3 devices under product code SAP between 2024 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SAP

Adverse events under product code SAP

product code SAP
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code SAP

Data sourced from openFDA. This site is unofficial and independent of the FDA.