CHAMBER FOR MILD HYPERBARICS
Received Jun 4, 2006
Report MW1039455 · MDR key 726092
Device
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.