Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213533 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)
The Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, and SC-4008-DL are powered inflatable tube massagers designed for physical medicine applications. These devices use sequential compression to promote venous return, reduce edema, and improve lymphatic drainage in patients with conditions such as lymphedema or peripheral edema.
These devices are intended for single-use or reusable settings, depending on the model and clinical protocol. They are classified as Class II medical devices under FDA regulations and comply with the Medical Device Directive (MDD). The units vary in chamber configuration (4 or 8 chambers) and are supplied sterile or non-sterile as specified for use in clinical environments. No MRI safety information is provided, and proper storage and maintenance are required to ensure functionality and hygiene.
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: May 14, 2021 Bio Compression Systems, Inc. Marc Somelofski ..., SC-4004-DL - BioCompression Systems, MOHAP - Registered Medical Products Directory | PDF - Scribd, SC-2004-DL - BioCompression Systems, Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213533 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Compression Systems, Inc.
Sources (2)
- FDA 510(k) K213533 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced Jun 3, 2026