K-number	K152852
Device name	ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
Applicant	Bayer Healthcare, LLC
Product code	NUH
Device class	Class II
Decision date	Dec 22, 2015
Decision	Substantially Equivalent
Regulation	882.5890

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 →

ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)

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