VascuEase IC-1200-WH Compression Sleeve
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180248 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 VascuEase IC-1200-WH is a compressible limb sleeve, designed to apply graduated pressure to the lower extremities. It is classified as a Class II medical device and falls under the category of sleeves intended for vascular applications, aiding in venous return and reducing edema or discomfort associated with chronic venous insufficiency or lymphedema.
This device is supplied as a single-use, non-sterile sleeve and is intended for use in clinical or home settings. It is manufactured in various sizes to accommodate different limb circumferences and is regulated under FDA 510(k) clearance, MDD, and MDR compliance. The device is intended for application by trained personnel or patients under medical supervision, with no specific MRI safety restrictions noted.
Frequently asked questions
What is the primary purpose of the VascuEase IC-1200-WH sleeve, and how does it help patients?
The VascuEase IC-1200-WH is designed to apply graduated pressure to the lower extremities, improving venous return and reducing symptoms like swelling (edema) or discomfort caused by chronic venous insufficiency or lymphedema. By compressing the limb, it helps maintain circulation and supports recovery or management of these conditions.
Is the VascuEase IC-1200-WH intended for single-use or reusable applications, and what does that mean for my workflow?
The sleeve is single-use only, meaning it is not meant for reuse after one application. This design choice ensures hygiene and reduces the risk of contamination, which is particularly important in clinical or home settings where multiple patients or individuals may use compression therapy. Each sleeve must be discarded after use.
Are there different sizes available for the VascuEase IC-1200-WH, and how do I determine the correct fit for a patient?
Yes, the VascuEase IC-1200-WH is manufactured in multiple sizes to accommodate various limb circumferences. The exact sizing options are listed in the provided FEI numbers (e.g., 3000143502, 3004105270), which correspond to different circumference ranges. To determine the correct fit, measure the patient’s limb circumference at the widest point and match it to the manufacturer’s sizing chart.
Does the VascuEase IC-1200-WH require any special storage conditions, and how should it be handled before use?
The sleeve is non-sterile, so it does not require sterile storage conditions. However, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity. Before use, ensure the sleeve is free from tears or damage, and follow manufacturer guidelines for proper application to avoid improper compression.
Can the VascuEase IC-1200-WH be used safely in patients who require MRI scans, and what are the restrictions?
The device does not have specific MRI safety restrictions noted in its documentation, meaning it is unlikely to interfere with MRI procedures. However, always verify with the manufacturer or radiology department before use, as materials or components not explicitly labeled as MRI-safe could pose risks. Standard precautions for compression garments should still be followed.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180248 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Compression Systems, Inc.
Sources (2)
- FDA 510(k) K180248 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026