# K953796: Banks Hydro-Therapy Chair

- Pathway: 510(k) (Traditional)
- Applicant: Keith Products, Inc.
- Decided: Apr 1, 1996 after 231 days
- Product code: ILM (Bath, Sitz, Powered)
- 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
Longest line of descent: 1 generation back to K914125 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914125: Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403, Ferno (1991) Summary page 1.

## Indications for use
to aid in adding moisture to necrotic areas in order to aid in the debridement of wounds, to aid in the relief of pain and discomfort, to aid in the cleansing of open wounds, and as a form of physical therapy for certain types of pathologies.

Source page: https://510kreport.com/device/K953796
Methodology: https://510kreport.com/methodology