Cleared Traditional

ActiPatch(R) (K152432) - FDA 510(k) Clearance

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

K152432 · Bioelectronics Corporation · Physical Medicine device
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Feb 2017
Decision
526d
Days
Class 2
Risk

K152432 is an FDA 510(k) clearance for the ActiPatch(R). Classified as Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain (product code PQY), Class II - Special Controls.

Submitted by Bioelectronics Corporation (Frederick, US). The FDA issued a Cleared decision on February 3, 2017 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - the FDA physical medicine 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 Physical Medicine submissions.

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Submission Details

510(k) Number K152432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date February 03, 2017
Days to Decision 526 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
411d slower than avg
Panel avg: 115d · This submission: 526d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PQY Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
Definition Nonthermal Pulsed Electromagnetic Energy Intended For Over-the-counter Use For The Treatment Of Pain.
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 Physical Medicine devices follow this clearance model.