FDA.reportPublic FDA data

ZMI ELECTRONICS LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96174861000442645ZMI ELECTRONICS LTD.1N2026-01-016F-1, NO. 286-4, Shin Ya Rd., Chien Chen District, KAOHSIUNG TW 806

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04719872333104Levina - Levina Incontinence Stimulation Electrodes-vaginal+88678150053mail@zmi-electronics.com
04719872333593Levina - Levina Incontinence Stimulation Electrodes-(thin-long)+88678150053mail@zmi-electronics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
555631817599861K945509FX-2 NMS (2CHANNEL TABLE MODEL)IPF1995-05-02
555631817706629K945508FX-2P NMS (2 CHANNEL PORTABLE)IPF1995-05-02
555631452621182K915100BRINDLEY & SMITH ET-1000LIH1992-09-14
555632061705475K883893OMNISOUND(TM) 3000IMG1988-11-01
555631150043774K874076MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATORIPF1988-01-04
555631429734600K831147OMNIPROBE ELECTRICAL NERVE STIMULATORGZJ1983-07-18
555632026055902K821523OMNI TENSGZJ1982-06-16
555631189395957K241862Levina Pelvic Floor Muscle Stimulator (RS-48)KPI2025-03-27
555631277353887K231166Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe ElectrodesKPI2024-01-18
555631148259204K220997Wireless TENS/EMS, Bruno, AelaNUH2022-09-01
555631296854617K180865ZMI Self-Adhesive ElectrodesGXY2018-06-28
555631148894991K091540MTD 4000ITH2009-10-08
555631735898647K060191ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNITILY2006-07-12
555631045774368
555631625597931
555631837671871
555631263375891
555631263796252
555631300276998
555631373209395
555631641976273
555631645229691
555631806435041
555631916106348

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IPF31995-05-02
KPI22025-03-27
GZJ21983-07-18
NUH12022-09-01
GXY12018-06-28
ITH12009-10-08
ILY12006-07-12
LIH11992-09-14
IMG11988-11-01

PMN#

GUDID#