Compressible Limb and Circulation Therapy System, Model WHF-314 (POWER-Q1000)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080134 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)
This device is a Powered Inflatable Tube Massager, classified as a compressible limb and circulation therapy system. It delivers sequential pneumatic compression to the legs via four-chamber garments, promoting venous return and reducing edema or lymphedema in patients with circulatory or lymphatic disorders.
The system is intended for use in clinical settings, such as physical medicine and rehabilitation, and is supplied as a reusable medical device. It requires electrical power for operation and is not designed for MRI environments. Authorized under FDA 510(k) clearance (K080134) and MDR, the device adheres to regulatory standards for Class II devices under Regulation 890.5650. No sterility or single-use specifications are indicated.
Frequently asked questions
What clinical settings is this device primarily intended for and how does it help patients?
The COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM (Model WHF-314) is designed for clinical use in physical medicine and rehabilitation settings. It delivers sequential pneumatic compression via four-chamber garments to the legs, which promotes venous return and helps reduce edema or lymphedema in patients with circulatory or lymphatic disorders. This therapy is particularly useful for patients who require improved circulation or fluid management in their lower limbs.
Is this device reusable or single-use, and what does that mean for maintenance and cleaning?
The device is explicitly described as a reusable medical device, meaning it is intended for repeated use in clinical settings. Since it is not sterile or single-use, proper cleaning and maintenance protocols must be followed to ensure hygiene and functionality between uses. The manufacturer’s instructions should be consulted for specific cleaning guidelines.
What power source does this device require, and are there any restrictions on its use in medical environments?
The device requires electrical power for operation, so it must be plugged into a standard power outlet. It is not designed for use in MRI environments, meaning it should not be used in areas with magnetic resonance imaging equipment, as this could interfere with the device or the imaging process.
What regulatory pathways has this device undergone, and what does that mean for its use in clinical practice?
The device has been authorized under both FDA 510(k) clearance (K080134) and the EU’s Medical Device Regulation (MDR). This means it has been evaluated by regulatory authorities to meet safety and performance standards for Class II devices under FDA classification (IRP product code) and EU requirements. Clinicians can rely on its regulatory approvals as evidence of compliance with established medical device standards.
Are there different sizes or models available for this device, and how would I determine the right fit for a patient?
The device is listed as Model WHF-314 (Power-Q1000), but the provided data does not specify multiple sizes or models beyond this designation. To determine the appropriate fit for a patient, clinicians should refer to the manufacturer’s sizing guidelines for the four-chamber garments, which are likely designed to accommodate varying leg circumferences. The device’s sequential compression is standardized, so the garment size is the primary variable for patient-specific use.
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 Whf-314 (Power ..., Compressible Limb and Circulation Therapy System, Model Whf-314 (Power ..., PDF Compressible Limb and Circulation Therapy System, Model Whf-314 (Power ..., PDF JAN 2 3 2009 - Food and Drug Administration
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 | K080134 | Class II | Active |
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Manufacturer
- Manufacturer
- Wonjin Mulsan Co.ltd
- FDA Applicant
- Wonjin Mulsan Co., Ltd.
Sources (2)
- FDA 510(k) K080134 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026