actiTENS mini— 510(k) K252767

Substantially Equivalent

Sublimed

FDA 510(k) clearance K252767 for actiTENS mini, Substantially Equivalent on 2026-01-16. Applicant: Sublimed. Device class: 2.

Clearance details

Applicant: Sublimed
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2025-08-29
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moirans, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

K252712 — STIMPOD NMS460 Nerve Stimulator2026-05-28
K252236 — CP Relief Wand Rx - TENS/NMES2025-08-15
K232441 — Unipro (K-UNIPRO-US)2024-08-30
K241228 — TENSWave2024-08-27
K233046 — Electrical Neuromuscular Stimulator, Cure Trio2024-04-19

More clearances from Sublimed

K202159 — actiTENS2020-12-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.