K-number	K960624
Device name	CERTI COOL INSTANT COLD COMPRESS
Applicant	Certified Safety Mfg., Inc.
Product code	IMD
Device class	Class I
Decision date	May 6, 1996
Decision	Substantially Equivalent for Some Indications
Regulation	890.5710

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 →

CERTI COOL INSTANT COLD COMPRESS

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