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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 K250190
Device Name Sequential Compression System (SCD600)
Applicant
Shenzhen Comen Medical Instruments Co.,Ltd
Floor 10, Floor 11 And Section C Of Floor 12 Of Bldg. 1a
& Floor 1 To Floor 5 Of Bldg. 2, Fiyta Timepiece Bldg.
Shenzhen,  CN 518106
Applicant Contact Zitong Wang
Correspondent
Shenzhen Comen Medical Instruments Co.,Ltd
Floor 10, Floor 11 And Section C Of Floor 12 Of Bldg. 1a
& Floor 1 To Floor 5 Of Bldg. 2, Fiyta Timepiece Bldg.
Shenzhen,  CN 518106
Correspondent Contact Zitong Wang
Regulation Number870.5800
Classification Product Code
JOW  
Date Received01/23/2025
Decision Date 12/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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