HMS-1000

GUDID 00860006478964

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.

Hyperbaric Modular Systems Inc.

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• Primary Device ID: 00860006478964
• NIH Device Record Key: 92976fe8-6695-497c-af96-91b72aa64f9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMS-1000
• Version Model Number: HMS-1000
• Company DUNS: 831644005
• Company Name: Hyperbaric Modular Systems Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006478964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052866

FDA Product Code

• CBF: Chamber, Hyperbaric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-10
• Device Publish Date: 2023-08-02

Devices Manufactured by Hyperbaric Modular Systems Inc.

• 00860006478940 - HMS-2000: 2023-08-10 The HMS-2000 is a Class A, single compartment pressure vessel for human occupancy (PVHO) that is oriented in a vertical cylindri
• 00860006478964 - HMS-1000: 2023-08-10The 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.
• 00860006478964 - HMS-1000: 2023-08-10 The HMS-1000 hyperbaric chamber series is a Class B, monoplace hyperbaric chamber designed to treat one (1) patient to a maximum
• 00860006478926 - HMS-4000: 2023-08-09 The HMS-4000 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a horizontal cylindrical geometry. Con
• 00860006478902 - HMS-5000-COMPACT-QUADRO: 2022-11-08 The HMS-5000-12 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two