# K030119: Nanma Adjustable Constriction Ring

- Pathway: 510(k) (Traditional)
- Applicant: Nanma Mfg Co., Ltd.
- Decided: Aug 6, 2003 after 205 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 adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfhctiodiotence. The Nanma adjustable constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)

Source page: https://510kreport.com/device/K030119
Methodology: https://510kreport.com/methodology