Zmi Electronics L T D

FDA Filings

This page includes the latest FDA filings for Zmi Electronics L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9617486
FEI Number1000442645
NameTONY LEE
Owner & OperatorZMI ELECTRONICS, LTD.
Contact Address6F-1, NO. 286-4, SHIN YA RD --
KAOHSIUNG TW-NOTA 806 TW
Official Correspondent
  • YUTA - LEE
  • 886-7-8150053-22
US Agent
  • TONY LEE
  • 310 8693551
  • mail@zmi-electronics.com
Importing Logistics Registration
ImporterAvening LLC
Address2020 Clearfield Lane
Chattanooga, TN 37405 UNITED STATES
Importer TypeAgent
Importing Logistics Registration
ImporterCarewear Corp.
Address1501 S. Arlington Ave
Reno, NV 89509 UNITED STATES
Importing Logistics Registration
ImporterPowerdot, Inc.
Address5900 Sea Lion Place, Ste 100
Carlsbad, CA 92010 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9210 Coolidge Road
Fairview, WA 98903 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
ZMI ELECTRONICS LTD.
 Levina SAE-MPBFPK22024-02-27
ZMI ELECTRONICS LTD.
 Levina SAE-MPBFBL22024-02-27
ZMI ELECTRONICS LTD.
 Levina SAE-MPBFBL12024-02-27
ZMI ELECTRONICS LTD.
 Levina SAE-MPBFPK12024-02-27
ZMI ELECTRONICS LTD.
 Levina SAE-MPBFPK2024-02-27
ZMI ELECTRONICS LTD.
 Levina SAE-MPBFBL2024-02-27
ZMI ELECTRONICS LTD.
 Levina RS-382024-02-27
ZMI ELECTRONICS LTD.
 Levina RS-182024-02-27
ZMI ELECTRONICS LTD.
 NeuroMD RS-18-MD2023-06-23
ZMI ELECTRONICS LTD.
 PowerDot 2021-08-09
ZMI ELECTRONICS LTD.
 PowerDot 2019-12-18
ZMI ELECTRONICS LTD.
 PowerDot 2019-12-18
ZMI ELECTRONICS LTD.
 PowerDot PD-01MT2019-12-18
TONY LEE [ZMI ELECTRONICS, LTD.]
PowerDot(R) PD-01MT Muscle Stimulator (with PowerDot (R) Mobile Application)2019-03-29
TONY LEE [ZMI ELECTRONICS, LTD.]
PowerDot(R) PD-01MT Muscle Stimulator (with PowerDot (R) Mobile Application)2019-03-29
TONY LEE [ZMI ELECTRONICS, LTD.]
PowerDot(R) PD-01MT Muscle Stimulator (with PowerDot (R) Mobile Application)2019-03-29
TONY LEE [ZMI ELECTRONICS, LTD.]
PowerDot(R) PD-01MT Muscle Stimulator (with PowerDot (R) Mobile Application)2019-03-29
ZMI ELECTRONICS LTD.
 ZMI 2019-01-14
ZMI ELECTRONICS LTD.
 ZMI 2019-01-14
ZMI ELECTRONICS LTD.
 CareWear ® 2019-01-08
ZMI ELECTRONICS LTD.
 ZMI SAE-MC-B2018-09-24
ZMI ELECTRONICS LTD.
 ZMI SAE-MC-R2018-09-24
TONY LEE [ZMI ELECTRONICS, LTD.]
ZMI Self-Adhesive Electrodes2018-08-13
ZMI ELECTRONICS LTD.
 Mettler MTD40002018-07-06
ZMI Electronics, Ltd.
ZMI Self-Adhesive Electrodes2018-06-28
ZMI ELECTRONICS LTD.
 PowerDot PD-01M2018-03-29
ZMI ELECTRONICS LTD.
 PowerDot PD-01M2018-03-29
ZMI ELECTRONICS LTD.
 PowerDot PD-012018-03-29
ZMI ELECTRONICS LTD.
 PowerDot PD-012018-03-29
ZMI ELECTRONICS LTD.
 PowerDot PD-012018-03-29
TONY LEE [ZMI ELECTRONICS, LTD.]
PowerDot(R) PD-01M Muscle Stimulator (with PowerDot (R) Mobile Application)2018-02-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Carewear CWC-12018-02-08
TONY LEE [ZMI ELECTRONICS, LTD.]
WalkAide System2016-10-05
TONY LEE [ZMI ELECTRONICS, LTD.]
PowerDot(R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application)2015-10-07
TONY LEE [ZMI ELECTRONICS, LTD.]
Rolyan Smart Handle, Rolyan Smart Handle Pro2014-05-27
TONY LEE [ZMI ELECTRONICS, LTD.]
ET-1000 Stim including Rubber Electrode2013-06-27
TONY LEE [ZMI ELECTRONICS, LTD.]
UniSmart Handle2012-08-21
TONY LEE [ZMI ELECTRONICS, LTD.]
UniSmart Handle Basic, UniSmart Handle Pro2012-08-21
TONY LEE [ZMI ELECTRONICS, LTD.]
MTD 40002009-10-27
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnistim Sport Elite2008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnistim FX22008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnistim FX2 Pro2008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnistim FX2 Pro Sport2008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnistim FX2 Portable2008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnisound 3000E2008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnistim 500C Pro2008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnistim 500B2008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnistim 5002008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Neuroprobe 5002008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
Omnistim FX2 Portable2008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
IR THERAPY PAD LGT-200LED2008-10-08
TONY LEE [ZMI ELECTRONICS, LTD.]
NEOPRENE STRAP2006-10-12

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020061852794Shilong,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL ACCESSORIES HTS CODE 901890 AMS 11CTNS11 PKG
2020051426580Kaohsiung,China (Taiwan) -> Long Beach, CaliforniaPOWERDOT WEARABLE DEVICES493 CTN
2020051338526Shilong,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL ACCESSORIES HS CODE 901890 AMS 13CTNS13 PKG
2020042427522Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL ACCESSORIES21 PKG
2020020652342Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL ACCESSORIES11 PKG
2020012541996Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaPOWERDOT WEARABLE DEVICE49 CTN
2020012539575Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL ACCESSORIES14 PKG
2019120524135Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL ACCESSORIES7 PKG
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