Cleared Traditional

actiTENS mini

K252767 · Sublimed · Neurology

Jan 2026

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K252767 is an FDA 510(k) clearance for the actiTENS mini, 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 January 16, 2026, 140 days after receiving the submission on August 29, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K252767 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2025
Decision Date	January 16, 2026
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF