BioArterial Plus Arterial Blood Flow Enhancement System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131327 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 BioArterial Plus Arterial Blood Flow Enhancement System is a Sleeve, Limb, Compressible device designed to enhance arterial blood flow in the lower extremities. It applies intermittent pneumatic compression to improve circulation, aiding patients with ischemic conditions such as intermittent claudication, rest pain, or arteriopathic wounds.
This system is intended for use in clinical settings and is supplied as a reusable device with multiple size options for limb application. It operates under FDA 510(k) clearance and MDD authorization, adhering to regulatory standards for cardiovascular applications. The device is not MRI-safe and requires proper storage and maintenance as specified in manufacturer instructions.
Frequently asked questions
What conditions is the BioArterial Plus system designed to help improve blood flow for in the lower extremities?
The BioArterial Plus Arterial Blood Flow Enhancement System is specifically designed to enhance arterial blood flow in patients with ischemic conditions, such as intermittent claudication, rest pain, or arteriopathic wounds in the lower extremities. It uses intermittent pneumatic compression to promote circulation.
Is the BioArterial Plus system reusable or single-use, and what size options are available?
The BioArterial Plus system is a reusable device, offering multiple size options for limb application. The exact sizing details are not specified in the data, but the system is designed to accommodate various lower limb circumferences for clinical use.
Can this device be used in an MRI environment, and what storage or maintenance requirements should be followed?
The BioArterial Plus system is explicitly stated as not MRI-safe, so it should not be used in MRI environments. Proper storage and maintenance must follow the manufacturer’s instructions, which are provided by Bio Compression Systems, Inc.
What regulatory pathways has the BioArterial Plus system followed for approval, and what classification does it fall under?
The device has obtained FDA 510(k) clearance under the traditional review pathway and MDD authorization, adhering to regulatory standards for cardiovascular applications. It is classified as a Class II device (per OpenFDA data) and falls under the Cardiovascular advisory committee for submissions.
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: Bio Compression Systems BioArterial Plus Manual, PDF Arterial Blood Flow Enhancement System Operating Instructions, Bio Compression Systems BioArterial Plus Manuals, IC-BAP-DL - BioCompression Systems
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 | K131327 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Compression Systems, Inc.
Sources (2)
- FDA 510(k) K131327 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026