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VenAir, Sequential Compression System (9P-089000) +7 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251466

by Wellell Inc.

Identifiers

510(k) Number
K251466 FDA 510(k)
FDA Product Code
JOW FDA 510(k)
Models / Variants
VenAir, Sequential Compression System (9P-089000) FDA 510(k)
VenAir, Sequential Compression System (PM01D01 / Calf garment (S)) FDA 510(k)
VenAir, Sequential Compression System (PM01E01 / Calf garment (M)) FDA 510(k)
VenAir, Sequential Compression System (PM01F01 / Calf garment (L)) FDA 510(k)
VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)) FDA 510(k)
VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)) FDA 510(k)
VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)) FDA 510(k)
VenAir, Sequential Compr 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)

VenAir, Sequential Compression System (9P-089000) +7 more models by Wellell Inc. — Class II — FDA_510K — listed in FDA 510(k) — 8 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wellell Inc.
FDA Applicant
Wellell, Inc.

Sources (1)

  • FDA 510(k) K251466 24 fields · synced Jun 18, 2026