# K971793: Very Private Intimate Moisture

- Pathway: 510(k) (Traditional)
- Applicant: Brandwynne Corp.
- Decided: Nov 24, 1997 after 193 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- 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
This intimate moisture lotion is indicated to relieve vaginal dryness instantly and enhance the pleasure of intimacy. It feels and functions like a woman’s own moisture. It is NOT A CONTRACEPTIVE.

Source page: https://510kreport.com/device/K971793
Methodology: https://510kreport.com/methodology