Cleared Traditional

ELEKIBAN MAGNETO-THERAPEUTIC DEVICE (K850172) - FDA 510(k) Clearance

K850172 · Mns, Ltd. · Physical Medicine device
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Apr 1985
Decision
90d
Days
-
Risk

K850172 is an FDA 510(k) clearance for the ELEKIBAN MAGNETO-THERAPEUTIC DEVICE.

Submitted by Mns, Ltd. (Washington, US). The FDA issued a Cleared decision on April 16, 1985 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K850172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1985
Decision Date April 16, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -