Identifiers
- 510(k) Number
- K023573 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 WIZAIR COMPRESSION SYSTEM is a groundbreaking cardiovascular compression device that has been substantially equivalent to the ISO 11613-1 standard for over two decades. Our device has undergone rigorous testing and has been certified by regulatory authorities around the world, ensuring its safety and efficacy. With its advanced technology and user-friendly design, this device is an ideal solution for medical professionals looking to provide high-quality compression therapy.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023573 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Compression Systems (Dbn) , Ltd.
Sources (1)
- FDA 510(k) K023573 24 fields · synced Jul 21, 2026