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Multiplace Hyperbaric Oxygen Treatment Chamber

FDA UDI

Class II (US FDA UDI)

by Fink Engineering Pty Ltd

Identity

Trade Name
Multiplace Hyperbaric Oxygen Treatment Chamber FDA UDI
Generic Name
Hyperbaric chamber, stationary FDA UDI
Device Name
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. FDA UDI
Model / Reference
TL20 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
TL20287CM09 FDA UDI
Primary DI / UDI-DI
B718TL20287CM090 FDA UDI
510(k) Number
K031649 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hyperbaric chamber, stationary

Multiplace Hyperbaric Oxygen Treatment Chamber by Fink Engineering Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hyperbaric chamber, stationary.

Cleared under the same submission

K031649 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fink Engineering Pty Ltd

Sources (1)

  • FDA UDI f289072d-790c-4dde-9b5a-d2d24a5705ed 35 fields · synced May 29, 2026