What is a Bag Chamber?

A bag chamber, sometimes referred to as soft chamber, mild hyperbaric chamber or Gamow bag, has  FDA “510(k)” clearance for marketing only for the treatment of acute mountain sickness (AMS) where at higher elevations there is less oxygen in the air and climbers become ill. Most of these devices are portable and are made from urethane-coated nylon which is sealed with a dual-zipper and design to treat at no greater than 4 psig of pressure (which equals 1.27 ATA or 9 feet of depth).

As an FDA Class II medical device, a licensed physician (MD or DO) prescription is mandatory for any use or purchase of the bag chamber. In addition, most States fire safety compliance is mandated in accordance with the National Fire Protection Association (NFPA) 99. Some States follow NFPA 101 Life Safety Code which invokes compliance with NFPA 99. This means the local fire marshal can insist that any clinic that uses hyperbaric chambers, including bag chambers, comply with codes which require the installation of fire walls, certified fire doors, sprinklers and other code compliance items.

The American Society of Mechanical Engineers (ASME) also mandates that all chambers that can increase pressure over 2 psig are designed to specific fabrication codes and be certified by the Pressure Vessel for Human Occupancy (PVHO-1) and embossed with the PVHO-1 stamp.  Most soft chambers have not been able to demonstrate that they comply with any recognized hyperbaric chamber design or fabrication standard.