SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.— 510(k) K052182

Name: FDA 510(k) clearance K052182
Creator: U.S. Food and Drug Administration
Published: 2005-11-04

Substantially Equivalent

Shian Jia Meei Enterprise Co., Ltd.

FDA 510(k) clearance K052182 for SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S., Substantially Equivalent on 2005-11-04. Applicant: Shian Jia Meei Enterprise Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shian Jia Meei Enterprise Co., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2005-08-10
Decision date: 2005-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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 Shian Jia Meei Enterprise Co., Ltd.

view all

K040311 — SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-3312004-10-01

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