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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(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.
# 9, Min Sheng St., Tu-Cheng Dist.
New Taipei City,  TW 236044
Applicant Contact Chieh Yang
Correspondent
Wellell, Inc.
# 9, Min Sheng St., Tu-Cheng Dist.
New Taipei City,  TW 236044
Correspondent Contact Chieh Yang
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/13/2025
Decision Date 10/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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