FDA 510(k) Applications Submitted by CHENG MING CHEN

FDA 510(k) Number Submission Date Device Name Applicant
K182411 09/04/2018 Scooter, Model: R-100 Yongkang Dingchang Industry & Trade Co., LTD.
K201982 07/17/2020 Air compression therapy system FO-3001; Air compression therapy system FO-3008 Foshan Hongfeng Co., Ltd
K212881 09/10/2021 Intense Pulsed Light (IPL) System Shenzhen Fansizhe Science And Technology Co., Ltd
K190534 03/04/2019 Manual Wheelchair SIVFH2A102 Jiangsu Horizon Medical Science & Technology Co., Ltd.
K081873 07/02/2008 EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE SHENZHEN EMPEROR ELECTRONIC TECHNOLOGY CO. LTD.
K213731 11/26/2021 EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows Ever Fortune.AI Co., Ltd.
K220103 01/12/2022 LED Therapy Device (Planar LED/Planar LED mini) Shenzhen Leaflife Technology Co., Ltd
K230362 02/10/2023 Planar LED mate Shenzhen Leaflife Technology Co., Ltd
K212697 08/25/2021 Leaf Smooth Shenzhen Leaflife Technology Co., Ltd
K202980 09/30/2020 Laser Therapy Device Shenzhen Leaflife Technology Co., Ltd
K212344 07/28/2021 Surgical Mask Xiantao Dingcheng Non-woven Product Co., Ltd
K212718 08/27/2021 Surgical gowns Xiantao Dingcheng Non-Woven Product Co., Ltd
K070473 02/20/2007 BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
K070578 03/01/2007 CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
K090027 01/05/2009 BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
K181276 05/14/2018 CONOD Enteral Feeding Sets Conod Medical Co., Limited
K201504 06/05/2020 Single-use medical poly (vinyl chloride) examination glove Anhui Bytech Medical Supplies Co., Ltd.
K210440 02/12/2021 Disposable Sampler Inactivated Transport Media, Nest ITM Wuxi Nest Biotechnology Co., Ltd.
K211256 04/26/2021 Disposable Sampler Viral Transport Media Wuxi Nest Biotechnology Co., Ltd.
K990750 03/08/1999 DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE WRP SPECIALTY PRODUCTS SDN. BHD.
K990752 03/08/1999 DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE WRP SPECIALTY PRODUCTS SDN. BHD.
K991044 03/30/1999 DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) WRP SPECIALTY PRODUCTS SDN. BHD.
K032461 08/11/2003 ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 Lin-Zhi International, Inc.
K970795 03/04/1997 SHANG HO SHANG HO INDUSTRIAL CORP. LTD.
K964819 12/02/1996 SHENG HO SHANG HO INDUSTRIAL CORP. LTD.
K142982 10/15/2014 OPUS 5100 Diagnostic Doppler Ultrasound System Chang Gung Medical Technology Co., Ltd.
K220118 01/14/2022 Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves KL-Kepong Rubber Products SDN. BHD.
K131042 04/15/2013 LEDEX DENTMATE TECHNOLOGY CO., LTD.
K221194 04/25/2022 LEDEX Dentmate Technology Co. Ltd.
K082408 08/21/2008 LEDEX, MODEL: WL-070 DENTMATE TECHNOLOGY CO., LTD.
K163605 12/21/2016 LEDEX WL070+ DENTMATE TECHNOLOGY CO., LTD.
K050733 03/17/2005 OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K050945 04/14/2005 ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS Lin-Zhi International, Inc.
K051058 04/26/2005 METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K051088 04/28/2005 MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K031797 06/10/2003 METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) Lin-Zhi International, Inc.
K032365 07/31/2003 BENZODIAZEPINE ENZYME IMMUNOASSAY Lin-Zhi International, Inc.
K032764 09/05/2003 BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) Lin-Zhi International, Inc.
K033094 09/29/2003 ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) Lin-Zhi International, Inc.
K033866 12/12/2003 CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) Lin-Zhi International, Inc.
K033885 12/15/2003 BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) Lin-Zhi International, Inc.
K142655 09/18/2014 CB PROT II Posterior Spinal System CHIN BONE TECHNIQUE CORP
K103015 10/12/2010 ODRC-DYNAMIC HIP SCREW SYSTEM ORTHOPAEDIC DEVICE RESEARCH CENTER
K172543 08/23/2017 High-speed Turbine Handpieces for Single Use Beijing Dongbo Dental Handpiece Co., Ltd.
K183041 11/01/2018 Full Digital Colour Doppler Ultrasonic Diagnostic System Wuhan Zoncare Bio-medical Electronics Co., Ltd
K181870 07/12/2018 Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use Wuhan W.E.O Science & Technology Development Co., Ltd.
K120181 01/20/2012 LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
K110219 01/25/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES WEALTH ON (JIANGSU) CO., LTD
K101000 04/12/2010 WELLMIEN SURGICAL MASK WELLMIEN (SUZHOU) IMPORT & EXPORT TRADING CO., LTD
K102171 08/02/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES WUXI BINGFA GAINLITE GLOVES CP., LTD
K102692 09/20/2010 SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO.
K112800 09/27/2011 SUNTOUCH TOPICAL HEMOSTATIC DRESSING HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
K143335 11/20/2014 Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) Roosin Medical Devices Co., Ltd


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