Cleared Special

K161663 - sTMS mini (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161663 · Eneura, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
68d
Days
Class 2
Risk

K161663 is an FDA 510(k) clearance for the sTMS mini. Classified as Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache (product code OKP), Class II - Special Controls.

Submitted by Eneura, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 23, 2016 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5808 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eneura, Inc. devices

Submission Details

510(k) Number K161663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2016
Decision Date August 23, 2016
Days to Decision 68 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 148d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OKP Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5808
Definition Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields That Are Externally Directed At Spatially Discrete Regions Of The Brain To Induce Electric Currents For The Treatment Of Migraine Headache.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.