FDA 510(k)

SpringTMS

K-Number: K182976 · 2019-02-25

Decision Date2019-02-25

Product CodeOKP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SpringTMS is the device name listed in this FDA 510(k) record. The listed applicant is Eneura®, Inc.. It received FDA 510(k) clearance on 2019-02-25 under 510(k) number K182976. 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 SpringTMS?

SpringTMS is a medical device that received FDA 510(k) clearance on 2019-02-25. The listed applicant is Eneura®, Inc.. The 510(k) number is K182976.

When did SpringTMS receive FDA 510(k) clearance?

SpringTMS received FDA 510(k) clearance on 2019-02-25, under 510(k) number K182976.

Who is the listed applicant for SpringTMS?

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 SpringTMS?

The FDA product code for SpringTMS 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 K162797SpringTMS K161663sTMS mini

Related Devices (Code: OKP)

K230358SAVI Dual (TM) Migraine TherapyEneura, Inc.K162797SpringTMSEneura, Inc.K161663sTMS miniEneura, 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.