# K993143: Vitality System

- Pathway: 510(k) (Traditional)
- Applicant: Soma Blue, Inc.
- Decided: Dec 27, 1999 after 97 days
- Product code: LKY (Device, External Penile Rigidity)
- Device class: 2
- Regulation: 21 CFR 876.5020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Vitality System consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant. The Vitality System’s intended use is to manage erectile dysfunction by allowing the creation of a full erection suitable for sexual activity. This is accomplished through the use of the manual vacuum pump to remove air from the cylinder, creating vacuum pressure within the cylinder. Blood is thereby drawn into the penis, causing it to become erect. The constriction ring is then placed around the base of the erect penis to restrict the outflow of blood. When activity is complete, the ring is removed from the base of the penis. This product is intended for over the counter use.

Source page: https://510kreport.com/device/K993143
Methodology: https://510kreport.com/methodology