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FDA 510(k)

PlasmaFlow X Compression Sleeve Device (XPF0001)

K-Number: K251446 · 2025-09-17

ApplicantManamed, LLC
Decision Date2025-09-17
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PlasmaFlow X Compression Sleeve Device (XPF0001) is a medical device manufactured by Manamed, LLC. It received FDA 510(k) clearance on 2025-09-17 under approval number K251446. 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 PlasmaFlow X Compression Sleeve Device (XPF0001)?

PlasmaFlow X Compression Sleeve Device (XPF0001) is a medical device that received FDA 510(k) clearance on 2025-09-17. It is manufactured by Manamed, LLC. The 510(k) number is K251446.

When was PlasmaFlow X Compression Sleeve Device (XPF0001) approved by the FDA?

PlasmaFlow X Compression Sleeve Device (XPF0001) received FDA 510(k) clearance on 2025-09-17, under approval number K251446.

What company makes PlasmaFlow X Compression Sleeve Device (XPF0001)?

PlasmaFlow X Compression Sleeve Device (XPF0001) is manufactured by Manamed, LLC.

What is the FDA product code for PlasmaFlow X Compression Sleeve Device (XPF0001)?

The FDA product code for PlasmaFlow X Compression Sleeve Device (XPF0001) is JOW.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment NOT_YET_RECRUITING 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 NCT07187726 Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk RECRUITING NCT07573189 The Effects of Recovery Compression Boots on Blood Lactate Levels, Functional Movement, and Joint Ange of Motion in Collegiate Athletes. ACTIVE_NOT_RECRUITING

Related Devices (Code: JOW)

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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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