FDA 510(k)

Foryou NPWT Dressing Kit

K-Number: K190119 · 2019-11-01

Decision Date2019-11-01

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Foryou NPWT Dressing Kit is a medical device manufactured by 4l Health Co., Ltd.. It received FDA 510(k) clearance on 2019-11-01 under approval number K190119. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Foryou NPWT Dressing Kit?

Foryou NPWT Dressing Kit is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by 4l Health Co., Ltd.. The 510(k) number is K190119.

When was Foryou NPWT Dressing Kit approved by the FDA?

Foryou NPWT Dressing Kit received FDA 510(k) clearance on 2019-11-01, under approval number K190119.

What company makes Foryou NPWT Dressing Kit?

Foryou NPWT Dressing Kit is manufactured by 4l Health Co., Ltd..

What is the FDA product code for Foryou NPWT Dressing Kit?

The FDA product code for Foryou NPWT Dressing Kit is OMP.

Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

Official Source

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