Cleared Traditional

K202079 - Physiq (FDA 510(k) Clearance)

K202079 · El.En Electronic Engineering Spa · Physical Medicine device

Nov 2020

Decision

121d

Days

Class 2

Risk

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

Submitted by El.En Electronic Engineering Spa (Calenzano, IT). The FDA issued a Cleared decision on November 25, 2020, 121 days after receiving the submission on July 27, 2020.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.

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