Foryou NPWT Dressing Kit— 510(k) K190119

Name: FDA 510(k) clearance K190119
Creator: U.S. Food and Drug Administration
Published: 2019-11-01

Substantially Equivalent

4l Health Co., Ltd.

FDA 510(k) clearance K190119 for Foryou NPWT Dressing Kit, Substantially Equivalent on 2019-11-01. Applicant: 4l Health Co., Ltd.. Device class: 2.

Clearance details

Applicant: 4l Health Co., Ltd.
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2019-01-24
Decision date: 2019-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huizhou, CN

Download summary PDF View on FDA.gov ↗

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K260646 — RENASYS EDGE (66803126)2026-05-27
K261291 — Nisus NPWT Canister 500-mL (CPC-500)2026-05-21

Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.