Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617486

FEI Number

1000442645

Entity Name

ZMI ELECTRONICS LTD.

City/State/Country

KAOHSIUNG, TW

Establishment Address

6F-1, NO. 286-4, Shin Ya Rd., Chien Chen District,, KAOHSIUNG 806, TW

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ZMI ELECTRONICS, LTD. (Owner Number: 9035676)

Owner / Operator Contact Address

6F-1, NO. 286-4, SHIN YA RD, --, KAOHSIUNG, TW-NOTA 806, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K831147

PMA Number

N/A

All Registered Proprietary Names

Carewear Firefly Wrinkle Reduction PowerDot(R) PD-01M Muscle Stimulator (with PowerDot (R) Mobile Application) Levina JointVive series Electrode Set NeuroMD RS-18 Wireless Muscle Stimulator Levina RS-38 Menstrual Pain Relief Stimulator Levina Magnetic PADS Levina RS-18 Wireless TENS/EMS Stimulator JointVive Wireless TENS/EMS STIMULATOR by Levina ZMI Self-Adhesive Electrodes IR THERAPY PAD LGT-200LED PowerDot(R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application) Omnistim FX2 Portable Omnistim 500 Omnistim 500B Omnistim 500C Pro Levina Pelvic Floor Muscle Stimulator MTD 4000 Omnistim FX2 Pro Sport Omnistim Sport Elite Omnistim FX2 Pro Omnistim FX2 PowerDot(R) PD-01M2 Muscle Stimulator (with PowerDot (R) Mobile Application) Omnistim FX2 Portable PowerDot(R) PD-01MT Muscle Stimulator (with PowerDot (R) Mobile Application) WalkAide System WalkAide System Carewear CWC-1 Neuroprobe 500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2020-12-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2018-02-08
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2023-03-02
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2023-03-02
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2023-03-02
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2018-08-13
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2008-10-08
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2015-10-07
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-10-08
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2008-10-08
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2025-04-22
ITH	Equipment, Traction, Powered	Physical Medicine	Class 2	890.5900	2009-10-27
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2008-10-08
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-08-09
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-08-09
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2019-03-27
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-08-09
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-08-09
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2008-10-08
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-03-29
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2019-03-29
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2019-03-29
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2019-03-29
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2016-10-05
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2016-10-05
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2018-02-08
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-10-08

Official Correspondent

YUTA LEE

US Agent Details

TONY LEE Email: mail@zmi-electronics.com Phone: (310) 8693551

Related Public Records

Same Entity

ZMI ELECTRONICS, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617486. Last updated year: 2026. Please use registration number 9617486 when referencing this establishment in official correspondence.