Cleared Traditional

K162797 - SpringTMS (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162797 · Eneura, Inc. · Neurology device
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Jun 2017
Decision
265d
Days
Class 2
Risk

K162797 is an FDA 510(k) clearance for the SpringTMS. 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 June 26, 2017 after a review of 265 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5808 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eneura, Inc. devices

Submission Details

510(k) Number K162797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2016
Decision Date June 26, 2017
Days to Decision 265 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 148d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.