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Hms-4000

FDA UDI

Class II (US FDA UDI)

by Hyperbaric Modular Systems, Inc.

Identity

Trade Name
HMS-4000 FDA UDI
Generic Name
Hyperbaric chamber, stationary FDA UDI
Device Name
The HMS-4000 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a horizontal cylindrical geometry. Configurations vary from one (1) to three (3) compartments. These chambers are capable of administering hyperbaric oxygen therapy treatments to four (4) up to twenty-four (24) patients simultaneously. These chamber models comprise the HMS 4000 Horizontal Cylindrical Multiplace Hyperbaric Chamber System Product Family. Each system consists of a multiplace hyperbaric chamber with several major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Design pressures range from 3ATA (~29.4psi) up to 6ATA (~73.5psi). The HMS-4000 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. FDA UDI
Model / Reference
HMS-4000 FDA UDI
Description
The HMS-4000 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a horizontal cylindrical geometry. Configurations vary from one (1) to three (3) compartments. These chambers are capable of administering hyperbaric oxygen therapy treatments to four (4) up to twenty-four (24) patients simultaneously. These chamber models comprise the HMS 4000 Horizontal Cylindrical Multiplace Hyperbaric Chamber System Product Family. Each system consists of a multiplace hyperbaric chamber with several major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Design pressures range from 3ATA (~29.4psi) up to 6ATA (~73.5psi). The HMS-4000 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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860006478926 FDA UDI
510(k) Number
K163109 FDA UDI
FDA Product Code
CBF FDA UDI
GMDN Term
Hyperbaric chamber, stationary FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5470 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hyperbaric chamber, stationary

Hms-4000 by Hyperbaric Modular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hyperbaric chamber, stationary.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hyperbaric Modular Systems, Inc.

Sources (1)

  • FDA UDI a7717600-f7cf-4cb7-84ab-ac9ba3dd2e2c 34 fields · synced Jun 8, 2026