Veinoflow SCD (Model LBTK-M-I 5006)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213313 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 Veinoflow SCD (Model LBTK-M-I 5006) is a Sleeve, Limb, Compressible device designed for sequential compression therapy. It applies graduated pressure to the legs, calves, or feet to promote venous return, reduce swelling, and prevent deep vein thrombosis (DVT).
This device is intended for single-use and is supplied sterile. It operates in a non-MRI-safe environment and is available in a single model configuration. Authorized under FDA 510(k) clearance (K213313) and MDR compliance, it is classified as a Class II Cardiovascular device (Product Code: JOW). Storage and handling follow standard medical device protocols.
Frequently asked questions
What is the primary purpose of the Veinoflow SCD (Model LBTK-M-I 5006) in clinical settings?
The Veinoflow SCD is designed for sequential compression therapy, applying graduated pressure to the legs, calves, or feet to improve venous blood flow, reduce swelling, and help prevent deep vein thrombosis (DVT). This makes it useful for patients at risk of circulatory issues or those recovering from procedures requiring limb support.
Is the Veinoflow SCD reusable or intended for single-use, and how does this affect its sterility?
The Veinoflow SCD is explicitly intended for single-use only, which ensures sterility is maintained for each application. Since it is supplied sterile, it eliminates the need for reprocessing or cleaning between uses, reducing infection risks.
Are there multiple sizes or models available for the Veinoflow SCD, or is it offered in a single configuration?
The Veinoflow SCD is available in a single model configuration (LBTK-M-I 5006), meaning it is designed to fit standard leg, calf, or foot sizes for sequential compression therapy. No additional sizing options are mentioned in the documentation.
How should the Veinoflow SCD be stored, and are there any special handling requirements?
The Veinoflow SCD follows standard medical device storage protocols, though specific instructions like temperature or humidity controls aren’t detailed. Since it’s sterile and single-use, it should be stored in a clean, dry environment away from direct sunlight or contaminants until use.
Can the Veinoflow SCD be used in environments where MRI scans are performed, or is it MRI-safe?
The device is not MRI-safe, meaning it should not be used in or near MRI environments. This is explicitly noted in the product description, so clinicians must ensure it’s removed before MRI procedures.
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: Veinoflow SCD (Model: LBTK-M-I 5006) (K213313) — FDA 510 (k ..., K213313 - Veinoflow SCD (Model: LBTK-M-I 5006) | FDA 510 (k), DVT pumps|DVT garments|IPC|LABTEK, PDF February 9, 2022 Dalian Labtek Science & Development Co., Ltd. ℅ Doris ...
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 | K213313 | Class II | Active |
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Manufacturer
- Manufacturer
- Dalian Labtek Science & Development Co., Ltd.
Sources (2)
- FDA 510(k) K213313 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026