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FDA 510(k)

SpringTMS

K-Number: K162797 · 2017-06-26

ApplicantEneura, Inc.
Decision Date2017-06-26
Product CodeOKP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SpringTMS is a medical device manufactured by Eneura, Inc.. It received FDA 510(k) clearance on 2017-06-26 under approval number K162797. 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 2017-06-26. It is manufactured by Eneura, Inc.. The 510(k) number is K162797.

When was SpringTMS approved by the FDA?

SpringTMS received FDA 510(k) clearance on 2017-06-26, under approval number K162797.

What company makes SpringTMS?

SpringTMS is manufactured by Eneura, Inc..

What is the FDA product code for SpringTMS?

The FDA product code for SpringTMS is OKP.

Other Devices by Eneura, Inc.

K161663sTMS mini K230358SAVI Dual (TM) Migraine Therapy

Related Devices (Code: OKP)

K161663sTMS miniEneura, 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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