510(k) K241096

Venera 608 Deep Vein Thrombosis (DVT) Prevention System by Suzhou Minhua Medical Apparatus Supplies Co., Ltd. — Product Code JOW

K241096 is an FDA 510(k) premarket notification submitted by Suzhou Minhua Medical Apparatus Supplies Co., Ltd. for the device "Venera 608 Deep Vein Thrombosis (DVT) Prevention System". The FDA issued a decision of Substantially Equivalent on January 15, 2025. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Suzhou Minhua Medical Apparatus Supplies Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2025
Date Received
April 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type