K-number	K100320
Device name	SLENDERTONE SYSTEM ULTRA MODEL E70/X70
Applicant	Bio-Medical Research, Ltd.
Product code	NGX
Device class	Class II
Decision date	May 5, 2010
Decision	Substantially Equivalent
Regulation	890.5850

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 →

SLENDERTONE SYSTEM ULTRA MODEL E70/X70

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