Cleared Traditional

actiTENS

K202159 · Sublimed · Neurology

Dec 2020

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K202159 is an FDA 510(k) clearance for the actiTENS, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Sublimed (Moirans, FR). The FDA issued a Cleared decision on December 22, 2020, 141 days after receiving the submission on August 3, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K202159 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2020
Decision Date	December 22, 2020
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF