Name: Predicase
Price: 199 USD

K-number	K251856
Device name	Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
Applicant	Everyway Medical Instruments Co.,Ltd
Product code	NUH
Device class	Class II
Decision date	Nov 21, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4

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