Data / Medical devices / Taiwan / Zmi Electronics Ltd.

Zmi Electronics Ltd.: FDA-registered device maker in Kaohsiung, Taiwan, 12 510(k) clearances

Name: Zmi Electronics Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zmi Electronics Ltd. is registered with the FDA (registration 9617486) in Kaohsiung, Taiwan. It lists 14 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 27, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Zmi Electronics Ltd.

FDA registration number: 9617486
FEI number: 1000442645
Address: 6F-1, NO. 286-4, Shin Ya Rd., Chien Chen District, Kaohsiung, Taiwan, 806
Owner or operator: ZMI ELECTRONICS, LTD. (9035676)
Roles: Contract manufacturer, Manufacturer
First device listed: October 8, 2008
Registered through: 2027
Brand names listed: Carewear CWC-1, Carewear Firefly Wrinkle Reduction, IR THERAPY PAD LGT-200LED, JointVive Wireless TENS/EMS STIMULATOR by Levina, Levina JointVive series Electrode Set, Levina Magnetic PADS, Levina Pelvic Floor Muscle Stimulator, Levina Pelvic Floor Probe and more

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Equipment, Traction, Powered	ITH	2	Manufacturer	accessdata.fda.gov
Gauge, Lens, Ophthalmic	HLN	1	Contract manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Contract manufacturer	accessdata.fda.gov
Perineometer	HIR	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 27, 2025	K241862	Levina Pelvic Floor Muscle Stimulator (RS-48)	KPI	Substantially Equivalent	Zmi Electronics , Ltd.	accessdata.fda.gov
January 18, 2024	K231166	Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes	KPI	Substantially Equivalent	Zmi Electronics , Ltd.	accessdata.fda.gov
September 1, 2022	K220997	Wireless TENS/EMS, Bruno, Aela	NUH	Substantially Equivalent	Zmi Elecronics , Ltd.	accessdata.fda.gov
June 28, 2018	K180865	ZMI Self-Adhesive Electrodes	GXY	Substantially Equivalent	Zmi Electronics , Ltd.	accessdata.fda.gov
October 8, 2009	K091540	MTD 4000	ITH	Substantially Equivalent	Mettler Electronics Corp.	accessdata.fda.gov
July 12, 2006	K060191	ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT	ILY	Substantially Equivalent	Accelerated Care Plus Corp.	accessdata.fda.gov
May 2, 1995	K945509	FX-2 NMS (2CHANNEL TABLE MODEL)	IPF	Substantially Equivalent	Fx-2	accessdata.fda.gov
May 2, 1995	K945508	FX-2P NMS (2 CHANNEL PORTABLE)	IPF	Substantially Equivalent	Fx-2	accessdata.fda.gov
November 1, 1988	K883893	OMNISOUND(TM) 3000	IMG	Substantially Equivalent	Physio Technology, Inc.	accessdata.fda.gov
January 4, 1988	K874076	MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR	IPF	Substantially Equivalent	Physio Technology, Inc.	accessdata.fda.gov
July 18, 1983	K831147	OMNIPROBE ELECTRICAL NERVE STIMULATOR	GZJ	Substantially Equivalent	Omni Intl., Inc.	accessdata.fda.gov
June 16, 1982	K821523	OMNI TENS	GZJ	Substantially Equivalent	Omni Intl., Inc.	accessdata.fda.gov

Compare with other makers

Updated March 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.