Shenzhen Dongdixin Technology Co L T D

FDA Filings

This page includes the latest FDA filings for Shenzhen Dongdixin Technology Co 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 Number3005170249
FEI Number3005170249
NameCHARLES MACK
Owner & OperatorSHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Contact AddressNo. 3 Building XiliBaimang Xusheng Industrial Estate, Nanshan
SHENZHEN CN-44 Guangdong 518108 CN
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2091 Oak Drive
Lake Havasu City, AZ 86406 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Shenzhen Dongdixin Technology Co., Ltd.
Levator Elite (Model LE9011)2022-02-25
Shenzhen Dongdixin Technology Co., Ltd.
Migraine Tens Digital Pain Reliever2021-06-17
Shenzhen Dongdixin Technology Co.,Ltd.
 CARETALK 2020-04-15
Shenzhen Dongdixin Technology Co.,Ltd.
 CARETALK 2020-03-27
Shenzhen Dongdixin Technology Co.,Ltd.
 Welby 2019-10-23
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Lactation Massager2019-07-28
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LV-LM1 (VT1000)2019-07-28
Shenzhen Dongdixin Technology Co.,Ltd.
 Little Journey 2018-08-31
Shenzhen Dongdixin Technology Co.,Ltd.
 Philips Avent ear thermometer 2018-08-20
Shenzhen Dongdixin Technology Co.,Ltd.
 Little Journey 2018-07-06
Shenzhen Dongdixin Technology Co.,Ltd.
 Philips ear thermometer 2018-07-06
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Wireless Pain Relieve Device2018-06-28
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Wireless Pain Relieve Device2018-06-28
Shenzhen Dongdixin Technology Co.,Ltd.
Wireless Pain Relieve Device2018-06-22
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT20612018-03-28
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Incontinence Treatment Device2018-03-28
Shenzhen Dongdixin Technology Co., Ltd
Incontinence Treatment Device, Model LT20612018-03-15
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Wireless Pain Relieve Device2017-12-10
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT5018C,LT5018E2017-12-10
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT1102S2017-12-10
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Wireless Pain Relieve Device2017-12-10
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT5018C,LT5018E2017-12-10
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT1102S2017-12-10
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Wireless Pain Relieve Device2017-12-10
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT5018C,LT5018E2017-12-10
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT1102S2017-12-10
Shenzhen Dongdixin Technology Co.,Ltd.
Wireless Pain Relieve Device Model: LT5018C2017-12-08
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
BW-TS1,BW-TSX,VM-WT12017-11-03
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
BW-TS1,BW-TSX,VM-WT12017-11-03
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT9000A,MT9000B,MT9000C2017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT8001,MT9001, MT9005, MT9006,MT9007,MT9008,MT9020,Care Tec IV,LG smart TENS2017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT80002017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT1201,LT5101,LT6101,LT7101,LT51022017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 102017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT9000A,MT9000B,MT9000C2017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT8001,MT9001, MT9005, MT9006,MT9007,MT9008,MT9020,Care Tec IV,LG smart TENS2017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT80002017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT1201,LT5101,LT6101,LT7101,LT51022017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 102017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT9000A,MT9000B,MT9000C2017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT8001,MT9001, MT9005, MT9006,MT9007,MT9008,MT9020,Care Tec IV,LG smart TENS2017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT80002017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT1201,LT5101,LT6101,LT7101,LT51022017-10-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 102017-10-20
Shenzhen Dongdixin Technology Co., Ltd.
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 102017-10-02
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Smart Pain Reliever2017-02-15
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT1102F2017-02-15
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Smart Pain Reliever2017-02-15
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT1102F2017-02-15
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Smart Pain Reliever2017-02-15
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT1102F2017-02-15
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
Smart Pain Reliever, Model LT50192017-02-08
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TH5001N2016-12-30
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TH1012(MBP70SN)2016-12-30
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TH1009N(KFT509),TH1009N-B2016-12-30
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Infrared Thermometer; KH8105 ( TH1012, TH1009N, TH1009N-B,TH5001N, 5001.200,1009.200,TH1110N,TH1009N-C)2016-12-30
Shenzhen Dongdixin Technology Co., Ltd.
Non-contact Forehead Thermometer2016-11-17
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Professional COMBO THERAPEUTIC DEVICE (STIMULATION AND/OR ULTRASOUND)2015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT2404,CT2400,CT2200,CT2201,CT2401,CT2203,MT2200,MT2201,MT2400,MT2401,UT22002015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Professional COMBO THERAPEUTIC DEVICE (STIMULATION AND/OR ULTRASOUND)2015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT2404,CT2400,CT2200,CT2201,CT2401,CT2203,MT2200,MT2201,MT2400,MT2401,UT22002015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Professional COMBO THERAPEUTIC DEVICE (STIMULATION AND/OR ULTRASOUND)2015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT2404,CT2400,CT2200,CT2201,CT2401,CT2203,MT2200,MT2201,MT2400,MT2401,UT22002015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Professional COMBO THERAPEUTIC DEVICE (STIMULATION AND/OR ULTRASOUND)2015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT2404,CT2400,CT2200,CT2201,CT2401,CT2203,MT2200,MT2201,MT2400,MT2401,UT22002015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Professional COMBO THERAPEUTIC DEVICE (STIMULATION AND/OR ULTRASOUND)2015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT2404,CT2400,CT2200,CT2201,CT2401,CT2203,MT2200,MT2201,MT2400,MT2401,UT22002015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Professional COMBO THERAPEUTIC DEVICE (STIMULATION AND/OR ULTRASOUND)2015-11-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT2404,CT2400,CT2200,CT2201,CT2401,CT2203,MT2200,MT2201,MT2400,MT2401,UT22002015-11-20
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
ComboRehab2015-11-13
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
UltraTENS2015-10-22
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT10322015-10-22
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
UltraTENS2015-10-22
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT10322015-10-22
Shenzhen Dongdixin Technology Co., Ltd
UltraTENS2015-08-26
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
VM-AP1, VM-MP1, VM-SNP12014-11-19
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Cutaneous Electrodes; Garment electrodes; Rubber electrodes2014-11-19
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
BW-EAC42014-11-19
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
AC10482014-11-19
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
GARMENT ELECTRODES2014-11-14
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
OTC EMS stimulator2014-06-20
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT10012014-06-20
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
OTC EMS STIMULATOR2014-06-16
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Shortwave diathermy therapeutic device2014-03-31
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
ST2200,ST23002014-03-31
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Lamp therapeutic device2014-03-31
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LS21002014-03-31
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
SW-THERM2014-03-14
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
LASER-STIM2013-12-27
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
OTC Electrical Stimulator and Electrodes2013-09-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT9001A,MT9001B,LT3060B2013-09-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT7012B(TEN603)2013-09-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT3062F2013-09-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT3040,LT3060,LT1101,LT1102,LT3042,LT3062,LT1102B,LT1102G, LT1009, TENS70002013-09-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
OTC Electrical Stimulator and Electrodes2013-09-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT9001A,MT9001B,LT3060B2013-09-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT7012B(TEN603)2013-09-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT3062F2013-09-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT3040,LT3060,LT1101,LT1102,LT3042,LT3062,LT1102B,LT1102G, LT1009, TENS70002013-09-21
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)2013-09-16
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT1023,UT1041,CT10222012-11-27
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
COMBO THERAPEUTIC DEVICE (STIMULATION AND/OR ULTRASOUND)2012-11-27
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT1023,UT1041,CT10222012-11-27
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
COMBO THERAPEUTIC DEVICE (STIMULATION AND/OR ULTRASOUND)2012-11-27
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
MT1023,UT1041,CT10222012-11-27
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
COMBO THERAPEUTIC DEVICE (STIMULATION AND/OR ULTRASOUND)2012-11-27
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
SONICSTIMU COMBO THERAPEUTIC DEVICE2012-11-21
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Electrode leads, patient cables2012-06-18
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Muscle Stimulator2012-06-14
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT30782011-08-11
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Care Back Pain Relief Stimulator2011-08-11
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR2011-08-03
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TH2081A2010-08-08
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TH1110A, TH1110B2010-08-08
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TH10722010-08-08
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TH1013(MBP69SN)2010-08-08
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TH1009C, TH2083, TH3003/TH3003N, TH1072,TH2081A, TH1002C,TH1002D,TH1110A, TH1110B, TH1009A,TH2081,TH2030,TH1081,TH1083)2010-08-08
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TH1002C,TH1002D2010-08-08
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
KH81052010-08-08
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Infrared Thermometer; KH8105 (TH1013,TH1091,TH2061,TH1003A,DX6635C,TH1050A,TH2071, TH1071, TH1002, TH1002A, TH1009,2010-08-08
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH10812010-07-22
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Portable Stimulation device2010-03-18
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT3011A, Ultima 202010-03-18
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Combo Stimulator2010-03-18
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Portable Stimulation device2010-03-18
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT3011A, Ultima 202010-03-18
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Combo Stimulator2010-03-18
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Portable Stimulation device2010-03-18
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
LT3011A, Ultima 202010-03-18
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Combo Stimulator2010-03-18
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT90032010-02-12
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Stimulator2010-02-05
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Intensity 50002010-02-05
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Stimulator2010-02-05
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Intensity 50002010-02-05
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR2010-01-29
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Portable ultrasound and stimulation device2010-01-19
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT2011,UT1032,UT10512010-01-19
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
Portable ultrasound and stimulation device2010-01-19
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
CT2011,UT1032,UT10512010-01-19
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
CT2011 SONICSTIMU PAIN RELIEF DEVICE2010-01-14
CHARLES MACK [SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.]
TENS2009-03-02
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
DX6605E-TENS, DX6605E-G, DX6609-G2009-02-26
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
INFRARED EAR THEMOMETER, MODELS DX6603, DX663902005-09-07

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NCAGE CodeSEDT6SHENZHEN DONGDIXIN TECHNOLOGY CO LIMITED
CAGE CodeSEDT6SHENZHEN DONGDIXIN TECHNOLOGY CO LIMITED
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