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 the device name listed in this FDA 510(k) record. The listed applicant is 4l Health Co., Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) 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. The listed applicant is 4l Health Co., Ltd.. The 510(k) number is K190119.

When did Foryou NPWT Dressing Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Foryou NPWT Dressing Kit?

The FDA 510(k) record lists 4l Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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)

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.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

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.