VenAir, Sequential Compression System (9P-089000) +6 more— 510(k) K251466

Name: FDA 510(k) clearance K251466
Creator: U.S. Food and Drug Administration
Published: 2025-10-28

Substantially Equivalent

Wellell, Inc.

FDA 510(k) clearance K251466 for VenAir, Sequential Compression System (9P-089000) +6 more, Substantially Equivalent on 2025-10-28. Applicant: Wellell, Inc.. Device class: 2.

Clearance details

Device name as filed: 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: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2025-05-13
Decision date: 2025-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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