Cleared Traditional

K122410 - I RUNE (I-200L)

K122410 is an FDA 510(k) clearance for I RUNE (I-200L), manufactured by Medirune Co, Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 461-day FDA review.

K122410 · Medirune Co, Ltd. · Neurology device
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Nov 2013
Decision
461d
Days
Class 2
Risk

K122410 is an FDA 510(k) clearance for the I RUNE (I-200L). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Medirune Co, Ltd. (Gangnam-Gu, KR). The FDA issued a Cleared decision on November 12, 2013 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Medirune Co, Ltd. devices

FDA 510(k) Submission Details - K122410

510(k) Number K122410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2012
Decision Date November 12, 2013
Days to Decision 461 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
313d slower than avg
Panel avg: 148d · This submission: 461d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
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.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 164
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