iStim S2 OTC Pain Relief TENS
K-Number: K181849 · 2018-08-10
Decision Date2018-08-10
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
iStim S2 OTC Pain Relief TENS is a medical device manufactured by Everyway Medical Instruments Co., Ldt.. It received FDA 510(k) clearance on 2018-08-10 under approval number K181849. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iStim S2 OTC Pain Relief TENS?
iStim S2 OTC Pain Relief TENS is a medical device that received FDA 510(k) clearance on 2018-08-10. It is manufactured by Everyway Medical Instruments Co., Ldt.. The 510(k) number is K181849.
When was iStim S2 OTC Pain Relief TENS approved by the FDA?
iStim S2 OTC Pain Relief TENS received FDA 510(k) clearance on 2018-08-10, under approval number K181849.
What company makes iStim S2 OTC Pain Relief TENS?
iStim S2 OTC Pain Relief TENS is manufactured by Everyway Medical Instruments Co., Ldt..
What is the FDA product code for iStim S2 OTC Pain Relief TENS?
The FDA product code for iStim S2 OTC Pain Relief TENS is NUH.
Other Devices by Everyway Medical Instruments Co., Ldt.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.