Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model Sqs
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122873 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vasopouse Deep Vein Thrombosis Compression Device is a sleeve, limb, compressible device designed to prevent or treat deep vein thrombosis (DVT) by applying sequential compression to the lower extremities. It promotes venous return, reduces blood pooling, and helps maintain circulation in patients at risk of or recovering from DVT, such as postoperative or immobilized individuals.
This device is supplied as a single-use, non-sterile sleeve in various sizes for the lower leg and thigh, intended for use in clinical settings such as hospitals, outpatient clinics, or home care. It is classified as Class II under FDA regulations (21 CFR 870.5800) and has received FDA 510K clearance and MDR authorization. Compatibility with MRI is not specified, and proper storage conditions must be followed to ensure functionality.
Frequently asked questions
What is the primary purpose of the Vasopouse Deep Vein Thrombosis Compression Device, and who is it designed for?
The Vasopouse Deep Vein Thrombosis Compression Device is designed to prevent or treat deep vein thrombosis (DVT) by applying sequential compression to the lower extremities. It promotes venous return, reduces blood pooling, and helps maintain circulation in patients at risk of or recovering from DVT, such as those who are postoperative or immobilized. The device is intended for use in clinical settings like hospitals, outpatient clinics, or home care.
Is the Vasopouse DVT Compression Device meant for single-use or reusable applications, and what does that mean for clinical workflows?
The Vasopouse DVT Compression Device is supplied as a single-use sleeve. This means each device is intended for one-time use on a single patient, reducing the risk of cross-contamination and simplifying inventory management in clinical workflows. Clinicians should follow manufacturer guidelines for proper disposal after use.
Are the Vasopouse DVT Compression Device sleeves sterile, and if not, what precautions should be taken before use?
The device is explicitly described as non-sterile, so it should not be used directly on a patient without proper preparation. Clinicians must follow standard aseptic techniques, such as cleaning the patient’s skin with an antiseptic solution, before applying the sleeve to minimize infection risk.
What sizes are available for the Vasopouse DVT Compression Device, and how do I determine the correct fit for a patient?
The device comes in multiple sizes for both the lower leg and thigh, as indicated by the extensive list of registration numbers (e.g., 3000143502, 3004105270). The manufacturer likely provides sizing charts or guidelines to match the patient’s limb circumference or measurements. Always verify the correct size to ensure proper compression and patient comfort.
How should the Vasopouse DVT Compression Device be stored to maintain its functionality?
The device requires adherence to proper storage conditions to ensure functionality. While specific details like temperature or humidity aren’t provided, it’s critical to follow the manufacturer’s instructions (likely included in the packaging) to avoid damage from moisture, extreme temperatures, or physical stress. Improper storage could compromise the device’s ability to deliver effective compression.
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 | K122873 | Class II | Active |
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Manufacturer
- Manufacturer
- Caremed Supply, Inc.
Sources (2)
- FDA 510(k) K122873 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026