FDA 510(k) Applications Submitted by JEN KE-MIN

FDA 510(k) Number Submission Date Device Name Applicant
K130017 01/02/2013 VALENTINE STEEL WHEELCHAIR VALENTINE INTL. LTD.
K050011 01/03/2005 WU'S POWERED WHEELCHAIR, MAMBO F 120 WU'S TECH CO., LTD.
K050010 01/03/2005 WU'S POWERED WHEELCHAIR, MAMBO 36X WU'S TECH CO., LTD.
K050042 01/07/2005 WU'S 4-WHEELED NEO SCOOTER, WT-XL4 WU'S TECH CO., LTD.
K090058 01/08/2009 YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB YA HORNG ELECTRONIC CO., LTD.
K140067 01/10/2014 QARDIOARM QARDIO, INC.
K020130 01/15/2002 ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M ROLOR ELECTRONICS CORP.
K070176 01/18/2007 MAXHEALTH MECHANICAL WHEELCHAIR, K1 MAXHEALTH CORP.
K220156 01/19/2022 Electrically Powered Wheelchair, Joy Rider Tung Keng Enterprise Co., Ltd.
K220155 01/19/2022 Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Motex Healthcare (Anhui) Co., Ltd.
K030221 01/21/2003 MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR MYTECH TECHNOLOGY CO., LTD.
K080242 01/31/2008 HEARTWAY POWER MOBILITY SCOOTER, PF7 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K050290 02/07/2005 LERADO, COSCO LERADO OVERSEA LTD. TWN BRANCH (BVI)
K040320 02/09/2004 SINON POWER WHEELCHAIR, SN-P401 SINON CORPORATION
K040319 02/09/2004 SINON POWER WHEELCHAIR, SN-W401 SINON CORPORATION
K070433 02/14/2007 LERADO, POWER WHEELCHAIR, PB LERADO CHINA LIMITED
K090389 02/17/2009 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM BESTGEN BIOTECH CORP.
K100480 02/18/2010 ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH VITALTEC CORPORATION
K070493 02/20/2007 HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT HEARTWAY MEDICAL PRODUCTS CO., LTD.
K070489 02/20/2007 HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT HEARTWAY MEDICAL PRODUCTS CO., LTD.
K040528 03/01/2004 AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T YA HORNG ELECTRONIC CO., LTD.
K090542 03/02/2009 SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 SUN-RAIN SYSTEM CORP.
K030707 03/06/2003 WU'S POWERED WHEELCHAIR, MAMBO 3 WU'S TECH CO., LTD.
K030709 03/06/2003 WU'S POWERED WHEELCHAIR, MAMBO 5 WU'S TECH CO., LTD.
K070655 03/09/2007 WU'S POWERED WHEELCHAIR, MAMBO 36 WU'S TECH CO., LTD.
K170787 03/16/2017 Powered Wheelchair DYW30A(D09) Nanjing Jin Bai He Medical Apparatus Co., Ltd.
K050708 03/18/2005 LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000 LERADO OVERSEA LTD. TWN BRANCH (BVI)
K050707 03/18/2005 LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000 LERADO OVERSEA LTD. TWN BRANCH (BVI)
K050788 03/28/2005 EVERLIFE EVERLIFE MEDICAL INSTRUMENT CO., LTD.
K110872 03/29/2011 WITHINGS BLOOD PRESSURE MONITOR WITHINGS
K121025 04/04/2012 YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION YA HORNG ELECTRONIC CO., LTD.
K130982 04/09/2013 LERADO, POWER WHEELCHAIR LERADO GLOBAL (MACAO COMMERCIAL OFFSHORE) LIMITED
K061007 04/11/2006 GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS GOOD MEDY ENTERPRISE LTD.
K040969 04/14/2004 POISE DATAENGINE POISE TECHNOLOGY CORPORATION
K150987 04/14/2015 HEARTWAY Power Mobility Scooter, BRIO S19 HEARTWAY Medical Products Co., Ltd.
K150998 04/15/2015 HEARTWAY Power Mobility Scooter HEARTWAY Medical Products Co., Ltd.
K191004 04/16/2019 Advocate Non-Contact Infrared Thermometer BroadMaster Biotech, Corp.
K021239 04/18/2002 EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M EIKON HEALTHCARE DEVICE CORP.
K021240 04/18/2002 EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200 EIKON HEALTHCARE DEVICE CORP.
K101143 04/22/2010 HEARTWAY POWER MOBILITY SCOOTER, S11 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K101142 04/22/2010 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K031310 04/24/2003 TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR TAI SHENG ELECTRICAL MACHINERY CO., LTD.
K031313 04/24/2003 TMC ELECTRICAL SCOOTER, EASY 405 TMC TECHNOLOGY CORP.
K031314 04/24/2003 TMC ELECTRICAL SCOOTER, EASY 411 TMC TECHNOLOGY CORP.
K031315 04/24/2003 TMC ELECTRICAL SCOOTER, EASY 321 TMC TECHNOLOGY CORP.
K091212 04/27/2009 WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H WU'S TECH CO., LTD.
K031370 04/30/2003 SHINMED MODE SW-988 UNTRASONIC NEBULIZER SHINING WORLD HEALTH CARE CO., LTD.
K181163 05/01/2018 Wu's Powered Wheelchair Wu's Tech Co., Ltd.
K041187 05/06/2004 A&I SCOOTER, SC-301 WELL SUCCESS BIOTECH INC.
K041190 05/06/2004 A&I POWER WHEELCHAIR, PC-401 WELL SUCCESS BIOTECH INC.
K041193 05/06/2004 A&I SCOOTER, SC-402 WELL SUCCESS BIOTECH INC.
K041228 05/10/2004 MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200 MYTECH TECHNOLOGY CO., LTD.
K071320 05/10/2007 EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 EVERLIFE MEDICAL EQUIPMENT CO., LTD.
K041336 05/19/2004 PRO WALKER PL-200 POWER WHEELCHAIR PRO WALKER INC.
K041337 05/19/2004 PRO WALKER ML-300 FOLDABLE WHEELCHAIR PRO WALKER INC.
K011701 06/01/2001 BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD.
K041465 06/02/2004 SINON SN-L402 LIGHTWEIGHT WHEELCHAIR SINON CORPORATION
K051473 06/03/2005 LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021 LERADO CHINA LIMITED
K021910 06/10/2002 COMFORT DREAMRIDER SCOOTER, LY-EW402 COMFORT ORTHOPEDIC CO. LTD.
K051539 06/10/2005 TRICOT BLOOD PRESSURE CUFF YA HORNG ELECTRONIC CO., LTD.
K011846 06/12/2001 BIOTECH POWERED WHEELCHAIR, C650PW ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
K031816 06/12/2003 DVNET MDV-PACS DVNET INTERNATIONAL TECHNOLOGY CO.,LTD.
K071624 06/14/2007 EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR EVERLIFE MEDICAL EQUIPMENT CO., LTD.
K041678 06/21/2004 KARMA POWER WHEELCHAIR, MODEL KP-25 KARMA MEDICAL PRODUCTS CO., LTD.
K041677 06/21/2004 KARMA SCOOTER, MODEL KS-747.2 KARMA MEDICAL PRODUCTS CO., LTD.
K111771 06/23/2011 NON-CONTACT TEAR FILM THERMOGRAGH UNITED INTEGRATED SERVICES CO., LTD.
K041752 06/29/2004 TEH LIN POWERED WHEELCHAIR, MDG-601 TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
K051863 07/08/2005 AMLUCK, YA HORNG YA HORNG ELECTRONIC CO., LTD.
K101999 07/15/2010 KAIYANG STEEL WHEELCHAIR GUANGDONG KAIYANG MEDICAL TECHNOLOGY CO., LTD.
K022369 07/22/2002 COMFORT WINDJOY SCOOTER, MODEL LY-EW302 COMFORT ORTHOPEDIC CO. LTD.
K042107 08/04/2004 TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 TUNG FU ELECTRIC CO., LTD.
K032489 08/12/2003 WU'S 4-WHEELED NEO SCOOTER, WT-M4JR WU'S TECH CO., LTD.
K032488 08/12/2003 WU'S 3-WHEELED NEO SCOOTER, WT-T3D WU'S TECH CO., LTD.
K022700 08/13/2002 DELUXE MANUAL WHEELCHAIR HW 4000 FOREVER YOUNG ENT. CO., LTD.
K022699 08/13/2002 TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR FOREVER YOUNG ENT. CO., LTD.
K022696 08/13/2002 TEH LIN POWERED WHEELCHAIR, MODEL MDG-201 TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
K032512 08/14/2003 Y.E.S POWERED WHEELCHAIR. T180 YEOU EIR SHUEN MACHINERY CO., LTD.
K072274 08/15/2007 MAJOR III BLOOD GLUCOSE MONITORING SYSTEM BESTGEN BIOTECH CORP.
K112392 08/18/2011 HIVOX BIOTEK INC. HIVOX BIOTEK, INC.
K062453 08/22/2006 KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138 KINGLY STAR INTL. TECHNOLOGY CO., LTD.
K122557 08/22/2012 MOTEX POWDER-FREE NITRILE SURGICAL GLOVES SHANGHAI MOTEX HEALTHCARE CO., LTD.
K132633 08/22/2013 OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD.
K032617 08/25/2003 WU'S 4-WHEELED SCOOTER, WT-L4JR WU'S TECH CO., LTD.
K132663 08/26/2013 I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM ALLIANCE INTERNATIONAL CO., LTD.
K192308 08/26/2019 Wu's Electrical Scooter Wu's Tech Co., Ltd.
K032645 08/27/2003 JUSTWIN SCOOTER, JS-3014 JOY RIDE TECH CO., LTD.
K032643 08/27/2003 JUSTWIN SCOOTER, JS-3013 JOY RIDE TECH CO., LTD.
K022917 09/03/2002 HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES HOME CARE TECHNOLOGY CO., LTD.
K122700 09/04/2012 PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES PROSBEN, INC.
K132802 09/06/2013 MOTEX POWDERED NITRILE SURGICAL GLOVES SHANGHAI MOTEX HEALTHCARE CO., LTD.
K182428 09/06/2018 GlucoLeader Enhance Blood Glucose Monitoring System HMD BioMedical Inc.
K212863 09/08/2021 Surgical Face Mask Taiwan Comfort Champ Manufacturing Co., Ltd.
K023040 09/12/2002 WU'S 3-WHEELED NEO SCOOTER, WT-L3 WU'S TECH CO., LTD.
K132856 09/12/2013 HEARTWAY POWER WHEELCHAIR HEARTWAY MEDICAL PRODUCTS CO., LTD.
K132855 09/12/2013 HEARTWAY POWER MOBILITY SCOOTER HEARTWAY MEDICAL PRODUCTS CO., LTD.
K032878 09/15/2003 KUNG SHIN, HMEF SK203 KUNG SHIN PLASTICS CO., LTD.
K052559 09/16/2005 WU'S POWERED WHEELCHAIR, MAMBO 2 WU'S TECH CO., LTD.
K062812 09/19/2006 DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N THUNDER TIGER CORP.
K112734 09/20/2011 APLAN A.V. FISTULA NEEDLE SET APLAN WELL ENTERPRISE CO., LTD
K042581 09/22/2004 AMLUCK, YA HORNG YA HORNG ELECTRONIC CO., LTD.
K102734 09/22/2010 COMFORT STANDING WHEELCHAIR, HERO SERIES COMFORT ORTHOPEDIC CO. LTD.
K023166 09/23/2002 WU'S 3-WHEELED NEO SCOOTER, WT-M4 WU'S TECH CO., LTD.
K023168 09/23/2002 WU'S 3-WHEELED NEO SCOOTER, WT-T3B WU'S TECH CO., LTD.
K033031 09/26/2003 TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR TAIWAN KING STRONG CO., LTD.
K033027 09/26/2003 SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 SHINING WORLD HEALTH CARE CO., LTD.
K142783 09/26/2014 HEARTWAY Electrically Powered Wheelchair P27 HEARTWAY Medical Products Co., Ltd.
K142785 09/26/2014 PRODIGY iConnect Blood Glucose Monitoring System OK BIOTECH CO., LTD.
K052671 09/27/2005 HOCA EZ-CARE BP108, TENDER-CARE BP109 HOCA MEDICAL MICROSYSTEM, INC.
K042653 09/28/2004 PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP PACK & PROPER CO., LTD.
K112816 09/28/2011 ZHENJIANG ASURE MECHANICAL WHEELCHAIR ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD
K033100 09/29/2003 TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01 TAIWAN KING STRONG CO., LTD.
K033097 09/29/2003 TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02 TAIWAN KING STRONG CO., LTD.
K133125 09/30/2013 WITHINGS BLOOD PRESURE MONITOR WITHINGS
K152878 09/30/2015 SUNTEC Mechanical Wheelchair, model ST-WL-1000 DANYANG SUNTEC AUTO PARTS CO., LTD.
K093084 10/01/2009 ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP ROLENCE ENT. INC.
K033204 10/02/2003 ESG 4-WHEEL SCOOTER, ESG-03 EMG TECHNOLOGY CO., LTD.
K033206 10/02/2003 EPW FOLDABLE POWER WHEELCHAIR, EPW-03 EMG TECHNOLOGY CO., LTD.
K033220 10/03/2003 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280 TUNG KENG ENTERPRISE CO., LTD.
K033213 10/03/2003 CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS CODENT TECHNICAL INDUSTRY CO., LTD.
K033219 10/03/2003 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600 TUNG KENG ENTERPRISE CO., LTD.
K063043 10/03/2006 SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP MODERN HEALTHCARE CORP.
K123115 10/03/2012 ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P ACME FILTER MASK INC.
K102935 10/04/2010 INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A KINGTECH ENTERPRISE, LTD.
K112950 10/04/2011 JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR JIANGSU HEALTHY MEDICAL EQUIPMENT CO;LTD
K112948 10/04/2011 JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO;LTD
K123126 10/04/2012 MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) SHANGHAI MOTEX HEALTHCARE CO., LTD.
K103046 10/14/2010 HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE HOSMAN INTERNATIONAL CO., LTD
K023581 10/24/2002 COMFORT AGILE SCOOTER, LY-EW303 COMFORT ORTHOPEDIC CO. LTD.
K083182 10/28/2008 DATACOM DC PACS DATACOM TECHNOLOGY CORP.
K013763 11/13/2001 WU'S 4-WHEELED NEO SCOOTER, WT-L4 WU'S TECH CO., LTD.
K153328 11/19/2015 SUNCO Mechanical Wheelchair, model SKW-9003 DANYANG SUNCO MACHINERY CO., LTD
K014126 12/17/2001 SANIDAD HEALTH-UP TENS MP-73725 ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
K033912 12/17/2003 CRADLE PACS CRADLE TECHNOLOGY CORP.


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