# K993343: Erecxel Adjustable Penile Bands, Contrex Adjustable Penile Bands

- Pathway: 510(k) (Traditional)
- Applicant: Erecxel Enterprises
- Decided: Mar 20, 2000 after 167 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
Longest line of descent: 1 generation back to K981180 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981180: Rejoyn Constriction Ring Kit, Pos-T-Vac B-100 Ring Kit, Pos-T-Vac B-25 Ring Kit and Pos-T-Vac B-10 Ring Kit, Pos-T-Vac, Inc. (1998) Summary page 1.

## Indications for use
The ERECXEL Adjustable Penile Bands are indicated as over-the-counter treatment for men with erection problem due to penile venous leakage. During erection, the ERECXEL Adjustable Penile Bands device helps to produce penile rigidity by constricting the penile veins around the base of the penis to restrict the flow of blood from leaving the penis.

Source page: https://510kreport.com/device/K993343
Methodology: https://510kreport.com/methodology