Name: Predicase
Price: 199 USD

K-number	K181688
Device name	R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
Applicant	Shenzhen Roundwhale Technology Co. , Ltd.
Product code	IPF
Device class	Class II
Decision date	Sep 7, 2018
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 →

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

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