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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2025-12-08 under 510(k) 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. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K250190.

When did Sequential Compression System (SCD600) receive FDA 510(k) clearance?

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

Who is the listed applicant for Sequential Compression System (SCD600)?

The FDA 510(k) record lists Shenzhen Comen Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Shenzhen Comen Medical Instruments Co.,Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)K211619Multi-Parameter Patient MonitorK191106C50 and C80 Multi-parameter Patient MonitorK173454Multi-parameter Patient Monitor, models C30

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K251466VenAir, 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 ComprWellell, Inc.

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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