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510(k) Data Aggregation
K Number
K102831Device Name
RSI 4200
Manufacturer
REIMERS SYSTEMS, INC.
Date Cleared
2011-08-19
(324 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
REIMERS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Specific indications for use of hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. The current specific indications are:
1. Air or Gas Embolism
2. Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by Cyanide Poisoning
3. Clostridial Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
5. Decompression Sickness
6. Enhancement of Healing in Selected Problem Wounds
7. Exception Blood Loss (Anemia)
8. Intracranial Abscess
9. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia)
10. Osteomyelitis (Refractory)
11. Radiation Tissue Damage (Osteoradionecrosis)
12. Skin Grafts and Flaps (Compromised)
13. Thermal Burns
Device Description
The model RST*200(™) hyperbaric chamber is a monoplace (one person) pressure chamber designed to be pressurized with air while is a monoplace (one person) presure chamber designed atmospheres absolute, ATA). atmospheres absolute, ATA).
The chamber comes with fixed tray system with comfortable custom mattress. The patient tray system is designed to accommodate a lying or sitting patient during a hyperbaric tray chamber is designed to accommodate a lying or sitting patient treatment. The chamber is designed to administer all of the standard treatment protocols for 3 ATA or less. The or less. The chamber includes the following sub systems:
1. Pressurization, Depressurization and Ventilation: This system includes pneumatically controlled valves and components. These valves and controls are used to control the pressurization rate and components. These valves and control and
2. Communications and Entertainment: The chamber is equipped with a system to facilitate clear and easy communication between the patient and changer operator. The communication system also permist the use of an auxiliary audion input for patient entertainment. Patient entertainment is anternational in input for patient entertainment Patient entertainment is automatically muted when withing audion the hand set from its cradle.
3. Windows: The chamber windows are positioned and sized to provide a feeling of comfort and spaciousness to
4. Oxygen Breathing System: The chamber is equipped with the necessary controls to administer oxygen to the patient whereby the patient wears a standard medical oxygen hood or mask.
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K Number
K962869Device Name
GSP1 - GAS SELECTION PANEL
Manufacturer
REIMERS SYSTEMS, INC.
Date Cleared
1996-10-23
(92 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
REIMERS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RSI GSP1 Gas Selection Panel is intended for use with hyperbaric oxygen (HBO) treatment gas systems whenever there is a need to select between two available gases. This typically includes support for monoplace chamber pressurization/ventilation systems and patient breathing gas systems supporting masks and hoods.
Device Description
The RSI gas selection panels (GSP1) are gas manifolds designed to accept two breathing gases. {Usually, air and oxygen will be specified; however, the device will work with any breathing gas.) Depending on the options selected, it will then supply one to four other devices. These other devices may be hyperbaric monoplace chambers (up to two) or patient breathing stations such as the RSI ODS1 Hood Driver (up to four). The GSP1 allows each device supplied to receive either qas.
The GSP1 incorporates a "block and bleed" gas circuit (like those used to supply mask breathing systems on larger multiplace hyperbaric chambers) that insures that the device supplied receives only the gas selected even if there is a leak in any of the other piping components. A positive means, such as the "block and bleed" design, is required to prevent contamination of one gas with another and is a safety requirement of the ASME PVHO-1 code.
The GSPI is designed to be surface mounted on a wall. It also has two service shut-off valves, one for each gas supply, and gauges to indicate supply pressures.
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K Number
K962871Device Name
ODS1 - HOOD DRIVER
Manufacturer
REIMERS SYSTEMS, INC.
Date Cleared
1996-10-23
(92 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
REIMERS SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hyperbaric chambers are used for treating the indications as currently listed by the Undersea Hyperbaric & Medical Association for hyperbaric oxygen therapy.
Device Description
The Model ODS1 - Hood Driver is intended for use with monoplace hyperbaric chambers. It is normally used to permit the patient to breath oxygen while the chamber is pressurized on air. However, it can be used to supply the patient with any physiologically appropriate gas which may or may not be the same as the gas used to pressurize the chamber. The ODSI circuit is designed to supply a steady flow of breathing gas to the breathing apparatus used in the chamber. The breathing apparatus can be either a "Sea-Long" hood or a free-flow mask arrangement.
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