# K022233: Hydroboot

- Pathway: 510(k) (Traditional)
- Applicant: Incappe, Inc.
- Decided: Aug 12, 2002 after 33 days
- Product code: DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs))
- Device class: 2
- Regulation: 21 CFR 880.5780
- 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 K963573 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981296: Geen Medisox, Geen Healthcare, Inc. (1998) Summary page 1.
- K963573: Elvarex, Jobst A Beiersdorf Co. (1996) Summary page 1.
- K020538: Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 Series, Boehringer Laboratories (2002)

## Indications for use
The HydroBoot provides comprehensive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema.

Source page: https://510kreport.com/device/K022233
Methodology: https://510kreport.com/methodology