DEVICE: HMS-1000 (00860006478964)
Device Identifier (DI) Information
HMS-1000
HMS-1000
In Commercial Distribution
Hyperbaric Modular Systems Inc.
HMS-1000
In Commercial Distribution
Hyperbaric Modular Systems Inc.
The HMS-1000 hyperbaric chamber series is a Class B, monoplace hyperbaric chamber designed to treat one (1) patient to a maximum operating pressure of three (3) Atmospheres Absolute (ATA) (~ 29.4 psi). The chamber uses 100% oxygen as both the pressurization and hyperbaric treatment gas. The overall external length of the horizontal cylinder configuration is 8.75 feet. Its internal diameter is 33.5 inches. It is constructed of acrylic, aluminum, and fine-grade steel. Single operator pressure control is achieved via a simple industrial Programmable Logic Device (PLD) controller. A low-voltage patient intercom provides communications between the patient in the chamber and the external chamber operators. HMS-1000 is designed, fabricated, and tested in compliance with the following FDA consensus standards: the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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12061 | Hyperbaric chamber, stationary |
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
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FDA Product Code
[?]Product Code | Product Code Name |
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CBF | Chamber, Hyperbaric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K052866 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
92976fe8-6695-497c-af96-91b72aa64f9a
August 10, 2023
1
August 02, 2023
August 10, 2023
1
August 02, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined