# K971443: Rapport V.T.D.

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford USA, Inc.
- Decided: Sep 26, 1997 after 158 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Osbon Erec-Aid: named in the summary without a submission number

## Most influential descendants
- K982275: Rapport V.T.D. (1998), 0 descendants of its own

## Indications for use
Intended to achieve a penile erection for males suffering from erectile dysfunction.

Source page: https://510kreport.com/device/K971443
Methodology: https://510kreport.com/methodology