# K050156: WHS-1000 Wound Healing System

- Pathway: 510(k) (Traditional)
- Applicant: Iyia Technologies, Inc.
- Decided: Jun 17, 2005 after 144 days
- Product code: KPJ (Chamber, Oxygen, Topical, Extremity)
- Device class: 2
- Regulation: 21 CFR 878.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K831825 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022028: VX-400 Topical Hyperbaric Oxygen Chamber, Vascular One, Inc. (2002) Summary page 1.

## Indications for use
The Misty TM Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy. The device is intended for the treatment of the following kinds of wounds: * skin ulcerations due to diabetes, venous stasis, and post surgical infections * gangrenous lesions, - decubitus ulcers * amputations/infected stumps * skin grafts * burns : frostbite

Source page: https://510kreport.com/device/K050156
Methodology: https://510kreport.com/methodology