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FDA 510(k)

Sequential Compression System (SCD600)

K-Number: K250190 · 2025-12-08

ApplicantShenzhen Comen Medical Instruments Co.,Ltd
Decision Date2025-12-08
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sequential Compression System (SCD600) is a medical device manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2025-12-08 under approval number K250190. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sequential Compression System (SCD600)?

Sequential Compression System (SCD600) is a medical device that received FDA 510(k) clearance on 2025-12-08. It is manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K250190.

When was Sequential Compression System (SCD600) approved by the FDA?

Sequential Compression System (SCD600) received FDA 510(k) clearance on 2025-12-08, under approval number K250190.

What company makes Sequential Compression System (SCD600)?

Sequential Compression System (SCD600) is manufactured by Shenzhen Comen Medical Instruments Co.,Ltd.

What is the FDA product code for Sequential Compression System (SCD600)?

The FDA product code for Sequential Compression System (SCD600) is JOW.

Related Clinical Trials

NCT07609511 Magnet System Gastric Outlet Obstruction Study NOT_YET_RECRUITING NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07305870 Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units ENROLLING_BY_INVITATION NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07317076 GT Metabolic Magnet System in Adults With Gastrointestinal Disorders RECRUITING

Other Devices by Shenzhen Comen Medical Instruments Co.,Ltd

K173454Multi-parameter Patient Monitor, models C30 K191106C50 and C80 Multi-parameter Patient Monitor K211619Multi-Parameter Patient Monitor K250854Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)

Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K161105Reprocessed Compression GarmentsCovidien K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP K161209Cirona 6400Devon Medical Products

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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