GEMORE TENS SYSTEM— 510(k) K120569

Substantially Equivalent

Gemore Technology Co, Ltd.

FDA 510(k) clearance K120569 for GEMORE TENS SYSTEM, Substantially Equivalent on 2012-07-20. Applicant: Gemore Technology Co, Ltd.. Device class: 2.

Clearance details

Applicant: Gemore Technology Co, Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2012-02-27
Decision date: 2012-07-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tan Shui, New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

K252712 — STIMPOD NMS460 Nerve Stimulator2026-05-28
K252767 — actiTENS mini2026-01-16
K252236 — CP Relief Wand Rx - TENS/NMES2025-08-15
K232441 — Unipro (K-UNIPRO-US)2024-08-30
K241228 — TENSWave2024-08-27

More clearances from Gemore Technology Co, Ltd.

K190988 — GIM-STIM OTC TENS/EMS System2019-08-16
K150681 — GEMORE OTC TENS2015-05-12
K122944 — GEMORE TRUE SINE INTERFERENTIAL STIMULATOR2012-12-21
K122948 — GEM-STIM COMBO STIMULATOR2012-12-21
K102933 — GEM-TONE BODY TRAINING SYSTEM2011-09-02

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