inforMED

CHAMBER FOR MILD HYPERBARICS

Received Jun 4, 2006

Report MW1039455 · MDR key 726092

Device

Generic name

Soft Bag

Manufacturer

Oxy-health Corp.

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Nonstandard Device

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

SOFT HYPERBARIC CHAMBERS ARE APPROVED BY THE FDA FOR THE TREATMENT OF ALTITUDE DECOMPRESSION ILLNESS ONLY. THIS IS DONE BY PRESSURIZING WITH AIR TO APPROXIMATELY 4 PSI OVER AMBIENT PRESSURE. THE USE OF ADDITIONAL OXYGEN IS SPECIFICALLY PROHIBITED BY THE FDA, BUT IS ROUTINELY IGNORED BY THOUSANDS OF USERS IN THE UNITED STATES. IN ADDITION, THE PRODUCT HAS NOT BEEN APPROVED BY THE PVHO CODE OF THE SOCIETY OF MECHANICAL ENGINEERS. THIS APPROVAL IS SPECIFICALLY REQUIRED BY CALIFORNIA AND MANY OTHER STATES. THE SOFT CHAMBERS CONTINUED TO BE MARKETED AND SOLD BY OXY-HEALTH CORP. CHIROPRACTERS IN MANY STATES ARE SOME OF THE WORSE OFFENDERS BY USING HIGH FLOW OXYGEN TO COMPRESS, I.E. AS A DRUG.