# K040772: Pacific Recumbent Height-Adjustable Bath System

- Pathway: 510(k) (Traditional)
- Applicant: Penner Manufacturing, Inc.
- Decided: Apr 5, 2004 after 10 days
- Product code: ILJ (Bath, Hydro-Massage)
- Device class: 2
- Regulation: 21 CFR 890.5100
- Recalls of this device: 10 (0 Class I)
- 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.

## Recalls of this device
- Aug 13, 2025 · Class III · Z-1505-2026: The device does not bear a unique device identifier.
- Aug 13, 2025 · Class III · Z-1503-2026: The device does not bear a unique device identifier.
- Aug 13, 2025 · Class III · Z-1504-2026: The device does not bear a unique device identifier.
- Aug 13, 2025 · Class III · Z-1507-2026: The device does not bear a unique device identifier.
- Aug 13, 2025 · Class III · Z-1501-2026: The device does not bear a unique device identifier.
- Aug 13, 2025 · Class III · Z-1502-2026: The device does not bear a unique device identifier.
- Aug 13, 2025 · Class III · Z-1508-2026: The device does not bear a unique device identifier.
- Aug 13, 2025 · Class III · Z-1499-2026: The device does not bear a unique device identifier.
- Aug 13, 2025 · Class III · Z-1500-2026: The device does not bear a unique device identifier.
- Aug 13, 2025 · Class III · Z-1506-2026: The device does not bear a unique device identifier.

## Indications for use
The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.

Source page: https://510kreport.com/device/K040772
Methodology: https://510kreport.com/methodology