Tony Lee

FDA Filings

This page includes the latest FDA filings for Tony Lee. 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)

Registration Number3005613467
FEI Number3005613467
NameTony Lee
Owner & OperatorNEW PROKIN INTERNATIONAL LTD.
Contact AddressNo.51,Huashixia St.,ShenChong Village, Torch Development Zone,
Zhongshan City CN-44 Guangdong 528437 CN
Official Correspondent
  • Kevin - Tsai
  • 86-760-88321570-103
US Agent
  • Tony Lee
  • 972 9053799
  • joyce.tsai@newprokin.com
Importing Logistics Registration
ImporterTommy International INC
Address45 Snawmut Road
Canton, MA 02021 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3729 Bella Vista Dr
Plano, TX 75074 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
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
TONY LEE [ZMI ELECTRONICS, LTD.]
ZMI Self-Adhesive Electrodes2018-08-13
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 [NEW PROKIN INTERNATIONAL LTD.]
ARC Baby Digital Thermometer2017-11-27
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
Tony Lee [NEW PROKIN INTERNATIONAL LTD.]
MEDICINE FEEDER2006-07-13
Tony Lee [NEW PROKIN INTERNATIONAL LTD.]
SYRINGE, ENT2006-07-13
Tony Lee [NEW PROKIN INTERNATIONAL LTD.]
TOOTHBRUSH, MANUAL2006-07-13
Tony Lee [NEW PROKIN INTERNATIONAL LTD.]
LIFT, PATIENT, NON-AC-POWERED2006-02-27
Tony Lee [NEW PROKIN INTERNATIONAL LTD.]
LIFT, PATIENT, NON-AC-POWERED SLING2006-02-27

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092989234Yantian,China (Mainland) -> Los Angeles, CaliforniaFINGERNAIL DECORATION ARTICLES1 PCS
2020092360981Yantian,China (Mainland) -> Long Beach, CaliforniaFINGERNAIL DECORATION ARTICLES1 PCS
2020091569905Yantian,China (Mainland) -> Los Angeles, CaliforniaKIMCCI FALSE EYELASH EXTENSION TRAI1 PCS
2020082582638Yantian,China (Mainland) -> Los Angeles, CaliforniaFINGERNAIL DECORATION ARTICLES1 PCS
2020082271368Yantian,China (Mainland) -> Los Angeles, CaliforniaFINGERNAIL DECORATION ARTICLES1 PCS
2020081583971Yantian,China (Mainland) -> Long Beach, CaliforniaFALSE EYELASHES1 PCS
2020081191666Yantian,China (Mainland) -> Los Angeles, CaliforniaFINGERNAIL DECORATION ARTICLES1 PCS
20200811107305Yantian,China (Mainland) -> Los Angeles, CaliforniaFINGERNAIL DECORATION ARTICLES1 PCS
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