# K980909: Vichy Shower

- Pathway: 510(k) (Traditional)
- Applicant: Bouvier Hydro, Inc.
- Decided: Aug 11, 1998 after 154 days
- Product code: ILJ (Bath, Hydro-Massage)
- Device class: 2
- Regulation: 21 CFR 890.5100
- 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
Vichy Shower is used in hydrotherapy to relieve pain and itching and as an aid in the removal of contaminated tissue, and in the healing process of inflamed and traumatized tissue.

Source page: https://510kreport.com/device/K980909
Methodology: https://510kreport.com/methodology