K251466 is an FDA 510(k) clearance for the VenAir, Sequential Compression System (9P-089000). This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Wellell, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on October 28, 2025, 168 days after receiving the submission on May 13, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K251466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2025 |
| Decision Date | October 28, 2025 |
| Days to Decision | 168 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |