# K051759: Flexi-Lite, Model FL-V1.2

- Pathway: 510(k) (Traditional)
- Applicant: Performance Hyperbarics
- Decided: Nov 17, 2005 after 141 days
- Product code: CBF (Chamber, Hyperbaric)
- Device class: 2
- Regulation: 21 CFR 868.5470
- 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 K874752 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874752: Gamow Hyperbaric Bag, Hyperbaric Aerobics, Ltd. (1988) Summary page 1.
- K001409: Gamow Bag, Hyper Oxy, Hyper Oxy P/T, Pressure-Cizer, Hyperbaric Technologies, Inc. (2000) Summary page 3.

## Most influential descendants
- K101262: Flexi-Lite (2010), 0 descendants of its own

## Indications for use
The Flexi-Lite Hyperbaric chamber is a rugged & portable hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician. Caution: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K051759
Methodology: https://510kreport.com/methodology