# K013053: Modification to Nanma Non-Adjustable Constriction Ring

- Pathway: 510(k) (Traditional)
- Applicant: Nanma Mfg Co., Ltd.
- Decided: May 9, 2002 after 240 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 non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. This device is intended for over-the-counter use (OTC)

Source page: https://510kreport.com/device/K013053
Methodology: https://510kreport.com/methodology