# K971507: O2 BOOT

- Pathway: 510(k) (Traditional)
- Applicant: Gwr Medical, Llp
- Decided: Nov 7, 1997 after 196 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: 1 generation back to K831825 (1983). 4 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831825: Dispos. Hyperbaric Oxygen Cush/Traum, Hospitak, Inc. (1983) Summary page 1.
- K840817: Disposable, Hyperbaric Oxygen Chamber, Hospitak, Inc. (1984) Summary page 1.
- K861593: Topical Hyperbaric Oxygen Chamber, Stephenson Industries, Inc. (1986) Summary page 1.
- K920948: Topical Sacral Hyperbaric Oxygen Chamber, Topox Therapeuutic Rentals, Inc. (1992) Summary page 1.

## Most influential descendants
- K023456: Oxybox System (2003), 4 descendants of its own
- K022028: VX-400 Topical Hyperbaric Oxygen Chamber (2002), 4 descendants of its own
- K080966: Hyper-Box Topical Wound Oxygen System (2008), 2 descendants of its own
- K212121: VHT-200 Wound Treatment System (2023), 1 descendant of its own
- K120764: Epiflo (R) (2012), 1 descendant of its own

## Indications for use
Indications for the O,;Boot are 1) skin uloerstions due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitus ulcers 3) amputations/infected stumps 4) skin grafts 5) burns 6) frostbite.

Source page: https://510kreport.com/device/K971507
Methodology: https://510kreport.com/methodology