Compressible Limb Therapy System Model WHF-324 (POWER-Q1000 Plus)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100656 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 Class II medical device under FDA regulations. It delivers sequential pneumatic compression to limbs, promoting circulation and reducing edema by inflating and deflating inflatable sleeves around the affected area. The system is designed for use in physical medicine settings to aid in venous return and lymphatic drainage, particularly for patients with conditions such as lymphedema, deep vein thrombosis, or post-surgical swelling.
The Compressible Limb Therapy System Model WHF-324 is supplied as a reusable device with disposable inflatable sleeves, intended for clinical use in controlled environments such as hospitals, rehabilitation centers, or outpatient clinics. It operates under FDA 510(k) clearance (K100656) and MDR compliance, adhering to regulatory standards for physical medicine applications. The system includes adjustable pressure settings and programmable sequences to accommodate different limb sizes and therapeutic needs, with storage requirements specified for clean, dry conditions to maintain functionality.
Frequently asked questions
What clinical settings is the Compressible Limb Therapy System Model WHF-324 intended for use in?
The Compressible Limb Therapy System Model WHF-324 is designed for clinical use in controlled environments such as hospitals, rehabilitation centers, or outpatient clinics. It is specifically intended for physical medicine applications to aid in venous return and lymphatic drainage, particularly for patients with conditions like lymphedema, deep vein thrombosis, or post-surgical swelling.
Are the inflatable sleeves for the WHF-324 reusable or disposable, and how does this affect clinical workflow?
The inflatable sleeves for the Compressible Limb Therapy System Model WHF-324 are disposable, which helps ensure hygiene and reduce cross-contamination between patients. This design aligns with clinical best practices for reusable medical devices in physical medicine settings, where single-use components minimize infection risks and simplify sterilization workflows.
What storage conditions are required to maintain the functionality of the WHF-324 device?
The device must be stored in clean, dry conditions to preserve its functionality. Since it is a reusable system with disposable sleeves, proper storage also helps prevent damage to the pneumatic components and ensures reliable operation for sequential pneumatic compression therapy.
How does the WHF-324 accommodate different limb sizes and therapeutic needs?
The system includes adjustable pressure settings and programmable sequences, allowing clinicians to customize treatment parameters for various limb sizes and patient conditions. This flexibility supports therapeutic applications for edema reduction, venous return enhancement, and lymphatic drainage in physical medicine settings.
What regulatory pathways does the WHF-324 follow, and how does this impact procurement?
The device is cleared under FDA 510(k) (K100656) and compliant with MDR (Medical Device Regulation) standards, confirming its classification as a Class II medical device. This regulatory status ensures adherence to safety and performance requirements for powered inflatable tube massagers, which may influence procurement decisions based on compliance needs and clinical validation.
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 Therapy System Model Whf-324 (Power-q1000 Plus), Compressible Limb Therapy System Model Whf-324 (Power-q1000 Plus), PDF User Manual_WHF-324_EN_Rev, FDA Browser - Cleared 510 (K) - COMPRESSIBLE LIMB THERAPY SYSTEM (K113275)
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 | K100656 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wonjin Mulsan Co.ltd
- FDA Applicant
- Wonjin Mulsan Co., Ltd.
Sources (2)
- FDA 510(k) K100656 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026