Wellell, Inc. · Class II · Cleared Oct 28, 2025
| K-number | K251466 |
| Device name | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr |
| Applicant | Wellell, Inc. |
| Product code | JOW |
| Device class | Class II |
| Decision date | Oct 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.5800 |
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