Compressible Limb and Circulation Therapy System, Model POWER-Q2300
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211283 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 Compressible Limb and Circulation Therapy System, Model POWER-Q2300, is a powered inflatable tube massager designed to improve circulation and reduce swelling in limbs. It applies sequential compression therapy through multi-chamber inflatable cuffs to enhance venous return and lymphatic drainage, supporting physical medicine applications.
This system is supplied as a reusable, AC-powered device comprising a control unit, power cord, hoses, and four inflatable cuffs (leg, arm, hip, and half-leg). It is classified as a Class II device under FDA regulation 890.5650 and has received FDA 510(k) clearance (K211283) and MDR authorization. The device is intended for use in clinical, hospital, athletic, and home settings, with no specific MRI safety restrictions noted.
Frequently asked questions
What types of limbs can the Compressible Limb and Circulation Therapy System, Model POWER-Q2300, treat and how does it work?
The POWER-Q2300 is designed to treat legs, arms, hips, and half-legs by applying sequential compression therapy through its multi-chamber inflatable cuffs. The system enhances venous return and lymphatic drainage, which helps improve circulation and reduce swelling in these areas. It is particularly useful for physical medicine applications, such as post-surgical recovery, chronic venous insufficiency, or athletic rehabilitation.
Is the Compressible Limb and Circulation Therapy System reusable or single-use, and what does that mean for maintenance?
The POWER-Q2300 is a reusable device, meaning the control unit, power cord, hoses, and inflatable cuffs are intended for repeated use. Since it is AC-powered and not disposable, maintenance involves regular cleaning and inspection of the reusable components to ensure proper function and hygiene, particularly in clinical or shared settings.
What cuff sizes or models are included with the Compressible Limb and Circulation Therapy System, and how do I know which one fits my patient?
The system includes four inflatable cuffs designed for legs, arms, hips, and half-legs, though the exact sizing details (e.g., circumference ranges) are not specified in the provided data. To determine the correct fit, refer to the manufacturer’s sizing guide or instructions, which likely outline measurements for each cuff type to match patient limb dimensions.
How should the Compressible Limb and Circulation Therapy System be stored, and are there any special handling instructions?
Since the POWER-Q2300 is reusable and includes inflatable cuffs, hoses, and a control unit, storage should be in a clean, dry environment to prevent damage or contamination. The cuffs should be stored in a way that avoids kinking or stretching, and the control unit should be kept away from moisture or extreme temperatures. Always follow the manufacturer’s instructions for proper storage and maintenance.
What regulatory pathways has the Compressible Limb and Circulation Therapy System followed, and where is it authorized for use?
The POWER-Q2300 has received FDA 510(k) clearance (K211283) under the traditional pathway, demonstrating substantial equivalence to a predicate device, and it holds MDR authorization. This means it is legally marketed in the U.S. and EU (or other MDR-compliant regions) for sequential compression therapy in clinical, hospital, athletic, and home settings, as defined by its regulatory filings.
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: Compressible Limb and Circulation Therapy System, Model POWER-Q2300, Compressible Limb and Circulation Therapy System, Model POWER-Q2300 510 ..., K211283 FDA 510(k) - Compressible Limb and Circulation Thera...
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 | K211283 | Class II | Active |
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Manufacturer
- Manufacturer
- Wonjin Mulsan Co.ltd
- FDA Applicant
- Wonjin Mulsan Co., Ltd.
Sources (2)
- FDA 510(k) K211283 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026