# K041573: Nanma Vacuum Pump Proxzek Model 2M9498S

- Pathway: 510(k) (Traditional)
- Applicant: Nanma Mfg Co., Ltd.
- Decided: Aug 25, 2004 after 72 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 Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erеctions in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)

Source page: https://510kreport.com/device/K041573
Methodology: https://510kreport.com/methodology