# K241897: MOR

- Pathway: 510(k) (Traditional)
- Applicant: Morari, Inc.
- Decided: Feb 11, 2025 after 228 days
- Product code: QRC (Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation)
- Device class: 2
- Regulation: 21 CFR 876.5026
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN210012 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223595: vPATCH, Virility Medical, Ltd. (2023) Summary page 5.

## Indications for use
The MOR System is indicated for the stimulation of healthy perineal muscles and nerves in adult males to improve or enhance sexual performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

Source page: https://510kreport.com/device/K241897
Methodology: https://510kreport.com/methodology