Cleared Traditional

K202079 - Physiq

K202079 is the FDA 510(k) clearance for Physiq by El.En Electronic Engineering Spa. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K202079 · El.En Electronic Engineering Spa · Physical Medicine device
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Nov 2020
Decision
121d
Days
Class 2
Risk

K202079 is an FDA 510(k) clearance for the Physiq. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by El.En Electronic Engineering Spa (Calenzano, IT). The FDA issued a Cleared decision on November 25, 2020 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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: 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 K202079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date November 25, 2020
Days to Decision 121 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 134
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