FDA 510(k)

sTMS mini

K-Number: K161663 · 2016-08-23

Decision Date2016-08-23

Product CodeOKP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

sTMS mini is the device name listed in this FDA 510(k) record. The listed applicant is Eneura, Inc.. It received FDA 510(k) clearance on 2016-08-23 under 510(k) 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. The listed applicant is Eneura, Inc.. The 510(k) number is K161663.

When did sTMS mini receive FDA 510(k) clearance?

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

Who is the listed applicant for sTMS mini?

The FDA 510(k) record lists Eneura, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for sTMS mini?

The FDA product code for sTMS mini is OKP.

Other records listing Eneura, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230358SAVI Dual (TM) Migraine Therapy K182976SpringTMS K162797SpringTMS

Related Devices (Code: OKP)

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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.