FESL FINK Chamber +2 more models
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240569 FDA 510(k)
- FDA Product Code
- CBF FDA 510(k)
- Models / Variants
- FESL FINK Chamber FDA 510(k)FEDL FINK Chamber FDA 510(k)FETL FINK Chamber FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5470 FDA 510(k)
- Regulation Number
- 868.5470 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FESL FINK Chamber; FEDL FINK Chamber; and FETL FINK Chamber are multiplace hyperbaric chambers designed for hyperbaric oxygen therapy. These devices are rectangular pressure vessels capable of accommodating between four and twenty-eight patients simultaneously. They operate at pressures up to 6.0 atmospheres absolute (ATA) and are intended for clinical use in medical facilities. These chambers incorporate systems for compressed air, oxygen delivery, environmental control, and fire protection, all managed via a control console.
These chambers are supplied as complete turnkey systems and are intended for use by clinical staff in accredited medical facilities. They are classified as Class II devices under FDA regulations and have received a 510(k) clearance (K240569) as substantially equivalent to a predicate device. The chambers are not single-use and require proper maintenance, storage, and adherence to hyperbaric safety protocols. No specific sterility claims are made, as these are reusable medical devices intended for repeated use in controlled clinical environments.
Frequently asked questions
What are the FESL, FEDL, and FETL FINK Chambers designed for?
These chambers are specifically designed for hyperbaric oxygen therapy (HBOT) in accredited medical facilities. They are rectangular pressure vessels capable of accommodating between four and twenty-eight patients simultaneously, allowing multiple patients to receive treatment at once. The chambers operate at pressures up to 6.0 atmospheres absolute (ATA), enabling therapeutic oxygen delivery under controlled conditions.
How are these chambers supplied, and what does a turnkey system include?
The FESL, FEDL, and FETL FINK Chambers are supplied as complete turnkey systems, meaning they come fully equipped and ready for clinical use. This includes integrated systems for compressed air, oxygen delivery, environmental control, and fire protection, all managed via a dedicated control console. No additional setup beyond installation and compliance with safety protocols is required.
Are these chambers single-use or reusable, and what sterility considerations apply?
These chambers are not single-use devices. They are reusable medical devices intended for repeated use in controlled clinical environments. Since they are not sterile by design, proper cleaning, maintenance, and adherence to hyperbaric safety protocols are essential before each use to ensure patient safety and device integrity.
What maintenance and storage requirements do these chambers have?
As reusable Class II devices, these chambers require regular maintenance to ensure operational safety and compliance with hyperbaric therapy standards. Storage should be in a clean, dry environment protected from physical damage or environmental contaminants. Follow the manufacturer’s guidelines for calibration, pressure testing, and component inspections to extend the device’s lifespan and reliability.
What distinguishes the FESL, FEDL, and FETL models from each other?
While the exact distinctions between the FESL, FEDL, and FETL models are not detailed in the provided data, they are all multiplace hyperbaric chambers with varying patient capacities (ranging from 4 to 28). Differences likely lie in design specifications (e.g., internal dimensions, configuration, or additional features) tailored for specific clinical needs. Contact the manufacturer for model-specific details, such as capacity or layout variations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (K240569) — FDA ..., Fink Engineering, FESL FINK Chamber; FEDL FINK Chamber; FETL FINK… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240569 | Class II | Active |
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Manufacturer
- Manufacturer
- Fink Engineering Pty Ltd
- FDA Applicant
- Fink Engineering Pty, Ltd.
Sources (1)
- FDA 510(k) K240569 24 fields · synced Oct 6, 2026