GEM-TWIN TENS/ MODELS GM3XY/Z— 510(k) K042559

Name: FDA 510(k) clearance K042559
Creator: U.S. Food and Drug Administration
Published: 2004-11-17

Substantially Equivalent

Gemore Technology Co, Ltd.

FDA 510(k) clearance K042559 for GEM-TWIN TENS/ MODELS GM3XY/Z, Substantially Equivalent on 2004-11-17. 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: 2004-09-21
Decision date: 2004-11-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Tan Shui, New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

view all

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.

view all

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
K120569 — GEMORE TENS SYSTEM2012-07-20

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