HMS-5000-COMPACT-QUADRO
Hyperbaric Modular Systems Inc. · Model HMS-5000-12 · UDI-DI 00860006478902
Description
The HMS-5000-12 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments and is capable of administering hyperbaric oxygen therapy treatments up to twelve (12) patients simultaneously. It is one of the models contained within the HMS 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family. It is comprised of a multiplace hyperbaric chamber with a number of major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Pressures up to 6ATA (~73.5psi). The HMS-5000 multiplace hyperbaric chamber is designed, fabricated, and tested in compliance with the following FDA consensus standards: American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-08-08 | Baro-Therapies, Inc | The firm is distributing the Rejuvenator device without an approved 510(k). |
| 2008-08-28 | Sechrist Industries Inc | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform |
| 2008-08-28 | Sechrist Industries Inc | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform |
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