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FDA 510(k)

sTMS mini

K-Number: K161663 · 2016-08-23

ApplicantEneura, Inc.
Decision Date2016-08-23
Product CodeOKP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

sTMS mini is a medical device manufactured by Eneura, Inc.. It received FDA 510(k) clearance on 2016-08-23 under approval number K161663. The device is classified under product code OKP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the sTMS mini?

sTMS mini is a medical device that received FDA 510(k) clearance on 2016-08-23. It is manufactured by Eneura, Inc.. The 510(k) number is K161663.

When was sTMS mini approved by the FDA?

sTMS mini received FDA 510(k) clearance on 2016-08-23, under approval number K161663.

What company makes sTMS mini?

sTMS mini is manufactured by Eneura, Inc..

What is the FDA product code for sTMS mini?

The FDA product code for sTMS mini is OKP.

Other Devices by Eneura, Inc.

K162797SpringTMS K230358SAVI Dual (TM) Migraine Therapy

Related Devices (Code: OKP)

K162797SpringTMSEneura, Inc. K182976SpringTMSEneura®, Inc. K230358SAVI Dual (TM) Migraine TherapyEneura, Inc.

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.

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