Air Compression Therapy System FO3002
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212169 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
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 FO3002 is a powered inflatable tube massager designed for physical medicine applications. It delivers sequential pneumatic compression to limbs, promoting circulation, reducing edema, and aiding in lymphatic drainage for patients with conditions such as lymphedema, deep vein thrombosis, or post-surgical recovery.
This system is intended for use in clinical settings, such as physical therapy or rehabilitation facilities, and is supplied as a reusable device. It operates under FDA 510(k) clearance and EU MDR compliance, with a classification as a Class II medical device. The system requires proper calibration and maintenance to ensure safe and effective operation, adhering to regulatory standards for air pressure and inflation cycles.
Frequently asked questions
What clinical conditions is this air compression therapy system primarily used to treat or manage?
The Air Compression Therapy System FO3002 is designed for physical medicine applications to promote circulation, reduce edema, and aid lymphatic drainage. It is specifically intended for patients with conditions such as lymphedema, deep vein thrombosis, or post-surgical recovery, helping improve recovery outcomes in clinical settings like physical therapy or rehabilitation facilities.
Is this device single-use or reusable, and what maintenance does it require?
The Air Compression Therapy System FO3002 is a reusable device, meaning it is intended for repeated use in clinical settings. To ensure safe and effective operation, it requires proper calibration and maintenance, including adherence to regulatory standards for air pressure and inflation cycles, as outlined in its design specifications.
What regulatory pathways has this device followed, and what does that mean for its use?
The device has obtained FDA 510(k) clearance and EU MDR compliance, classifying it as a Class II medical device. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device (for FDA) and meets EU safety, performance, and clinical requirements. Clinicians can rely on its compliance with these standards for safe clinical use in physical medicine applications.
How is this device supplied, and what types of limbs or body parts can it treat?
The system is supplied as a reusable powered inflatable tube massager designed for sequential pneumatic compression. It is intended for use on limbs, including arms and legs, to promote circulation, reduce swelling, and support lymphatic drainage. The inflatable tubes are adjustable to accommodate different limb sizes, making it versatile for various clinical applications.
What does the advisory committee classification (Physical Medicine) imply about the intended use of this device?
The advisory committee classification under Physical Medicine indicates that the device was reviewed by FDA’s Physical Medicine panel, which specializes in evaluating medical devices used to improve mobility, function, and recovery in patients. This classification does not define the device’s clinical indication but confirms that its intended use aligns with physical therapy and rehabilitation goals, such as edema management or post-surgical recovery.
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 | K212169 | Class II | Active |
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Manufacturer
- Manufacturer
- Foshan Hongfeng Co., Ltd.
Sources (2)
- FDA 510(k) K212169 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026