K-number	K202823
Device name	Innomed NPWT Silicone Foam Dressing
Applicant	Zhejiang Longterm Medical Technology Co., Ltd.
Product code	OMP
Device class	Class II
Decision date	Dec 15, 2021
Decision	Substantially Equivalent
Regulation	878.4780

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

Innomed NPWT Silicone Foam Dressing

Everything you need for a 510(k) submission. Nothing you don't.