Air Compression Therapy System FO-3001; FO-3008
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201982 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5650 FDA 510(k)
- Regulation Number
- 890.5650 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Air Compression Therapy System FO-3001 and FO-3008 are powered inflatable tube massagers designed for physical medicine applications. These devices apply sequential compression to limbs, promoting venous return, reducing edema, and improving circulation in patients with conditions such as lymphedema or chronic venous insufficiency.
These systems are intended for use in clinical or home settings and are supplied as reusable medical devices. They are classified as Class II under FDA regulations and comply with the Medical Device Regulation (MDR) in the EU. The systems require proper calibration, maintenance, and adherence to manufacturer instructions for safe operation. Authorized under FDA 510(k) clearance and MDR compliance, they are regulated for use in physical medicine specialties.
Frequently asked questions
What are the primary clinical applications for the Air Compression Therapy System FO-3001 and FO-3008?
These systems are designed for physical medicine applications, specifically to apply sequential compression to limbs. They help promote venous return, reduce edema, and improve circulation in patients with conditions like lymphedema or chronic venous insufficiency. The systems are suitable for both clinical and home use.
Are the Air Compression Therapy Systems FO-3001 and FO-3008 reusable or single-use devices?
The systems are classified as reusable medical devices. They require proper calibration, maintenance, and adherence to manufacturer instructions for safe and effective operation over multiple uses.
What regulatory pathways have these devices undergone, and where are they authorized for use?
The Air Compression Therapy Systems FO-3001 and FO-3008 are authorized under FDA 510(k) clearance and comply with the Medical Device Regulation (MDR) in the EU. They are classified as Class II devices under FDA regulations and are intended for use in physical medicine specialties.
How do I determine which model, FO-3001 or FO-3008, is appropriate for my needs?
The device data does not specify distinct clinical differences between the FO-3001 and FO-3008 models beyond their classification as powered inflatable tube massagers. Selection should be based on compatibility with your facility’s requirements, such as limb size coverage, pressure settings, and operational needs. Consult the manufacturer’s documentation for detailed specifications and recommendations.
What maintenance or calibration is required to ensure the safe operation of these systems?
The manufacturer emphasizes that proper calibration and maintenance are essential for safe operation. Regular adherence to the provided instructions is necessary to ensure the systems function correctly and reliably over time. Specific maintenance procedures should be referenced in the user manual provided by Foshan Hongfeng Co., Ltd.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201982 | Class II | Active |
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Manufacturer
- Manufacturer
- Foshan Hongfeng Co., Ltd.
Sources (2)
- FDA 510(k) K201982 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026