FDA 510(k) Applications Submitted by KE MIN JEN

FDA 510(k) Number Submission Date Device Name Applicant
K092650 08/27/2009 HEARTWAY POWER MOBILITY SCOOTER, S12 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K133113 09/30/2013 KINGTECH FOREHEAD THERMOMETER KINGTECH ENTERPRISE, LTD.
K052822 10/04/2005 DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 THUNDER TIGER CORP.
K052453 09/07/2005 TRACTION SYSTEM, DIGIT-TRAC 930 EVER PROSPEROUS INSTRUMENT, INC.
K042652 09/28/2004 TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR TAIWAN KING STRONG CO., LTD.
K160038 01/07/2016 UniStrip1 Generic Blood Glucose Test Strips OK BIOTECH CO., LTD.
K050087 01/13/2005 LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800 LERADO OVERSEA LTD. TWN BRANCH (BVI)
K020188 01/18/2002 BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD.
K040159 01/23/2004 APM BLOOD PRESSURE MONITOR, MODEL BP108A ASIA PACIFIC MICROSYSTEMS, INC.
K220227 01/27/2022 Auto Folding Scooter, S21F Heartway Medical Products Co., Ltd.
K020284 01/28/2002 BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD.
K050224 01/31/2005 3TEST GLUCOSE MONITORING SYSTEM NEUERO ENGINEERING INC.
K060251 01/31/2006 WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100 WELL HOME HEALTH PRODUCTS CO.
K030355 02/03/2003 COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 COMFORT ORTHOPEDIC CO. LTD.
K030356 02/03/2003 COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 COMFORT ORTHOPEDIC CO. LTD.
K100327 02/04/2010 HEARTWAY POWER CHAIR, P23 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K070350 02/06/2007 P&F POWER WHEELCHAIR, HC-510 P&F BROTHER IND.,CORP
K180355 02/08/2018 Advocate Non-Contact Infrared Thermometer BroadMaster Biotech, Corp.
K020471 02/12/2002 HIVOX EAR THERMOMETER, TS SERIES HIVOX BIOTEK, INC.
K020462 02/12/2002 SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 ROLOR ELECTRONICS CORP.
K020464 02/12/2002 SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 ROLOR ELECTRONICS CORP.
K020472 02/12/2002 BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD.
K090609 03/06/2009 OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD.
K060646 03/10/2006 BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 MONITEX INDUSTRIAL CO., LTD.
K020783 03/11/2002 TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB TELESIS TECHNOLOGIES INC.
K140650 03/13/2014 HIVOX ELECTRIC STIMULATOR OTC TENS HIVOX BIOTEK, INC.
K040678 03/15/2004 EUSURE BLOOD GLUCOSE MONITORING SYSTEM EUMED BIOTECHNOLOGY CO., LTD.
K070817 03/26/2007 LERADOTECH SCOOTER, MODEL SB LERADO CHINA LIMITED
K130848 03/26/2013 SHANGHAI PHOENIX MECHANICAL WHEELCHAIR SHANGHAI PHOENIX MEDICAL EQUIPMENT CO., LTD.
K070890 03/30/2007 EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 EVERLIFE MEDICAL EQUIPMENT CO., LTD.
K071005 04/09/2007 HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K071006 04/09/2007 HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K071007 04/09/2007 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K040968 04/14/2004 WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D WU'S TECH CO., LTD.
K071093 04/18/2007 SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 SAN SHIH ELECTRICAL ENTERPRISE CO., LTD.
K031309 04/24/2003 KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320 KUANN DAH INDUSTRY CO., LTD.
K161211 04/28/2016 Digital Thermometer BIOCARE ASIA CORPORATION LTD.
K091272 04/30/2009 BESMED JET NEBULIZER BOTTLE SET BESMED HEALTH BUSINESS CORP.
K051118 05/02/2005 MODEL TL-360 POWER SCOOTER TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
K051116 05/02/2005 MODEL TL-560 POWER SCOOTER TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
K021430 05/03/2002 SANIDAD TENS-DUO MODE GP8016N ROLOR ELECTRONICS CORP.
K041400 05/26/2004 FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 FORTIFIER INTERNATIONAL CO., LTD.
K051481 06/03/2005 JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP JAN MAO INDUSTRIES CO., LTD.
K051482 06/03/2005 JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP JAN MAO INDUSTRIES CO., LTD.
K201549 06/09/2020 Motex Anti-Fog Surgical Face Mask Modern Healthcare Corp.
K031818 06/12/2003 FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE FACILAI ENTERPRISES LTD.
K131720 06/12/2013 HIVOX SELF ADHESIVE ELECTRODE GEL PADS HIVOX BIOTEK, INC.
K021952 06/13/2002 HIVOX DREAMATE DM-800 HIVOX BIOTEK, INC.
K061694 06/15/2006 MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S MEDCARE MANUFACTURING INC.
K061693 06/15/2006 FORYOU POWERED WHEELCHAIR, MODEL FC-100 FORYOU TECHNOLOGY CO., LTD.
K151656 06/19/2015 HEARTWAY Power Mobility Scooter HEARTWAY MEDICAL PRODUCTS CO., LTD.
K191657 06/21/2019 Bioland Blood Glucose Monitoring System Bioland Technology Ltd.
K081924 07/07/2008 CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE CALHEALTH INC
K061959 07/11/2006 MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 MYTECH TECHNOLOGY CO., LTD.
K101998 07/15/2010 KAIYANG ALUMINUM WHEELCHAIR GUANGDONG KAIYANG MEDICAL TECHNOLOGY CO., LTD.
K141914 07/15/2014 PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD.
K092154 07/16/2009 HEARTWAY POWER MOBILITY SCOOTER, S9 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K092155 07/16/2009 HEARTWAY POWER MOBILITY SCOOTER, S8 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K141924 07/16/2014 HD BLOOD PRESSURE MONITOR BIOCARE ASIA CORPORATION LTD.
K141921 07/16/2014 HIVOX SPOPAD EMS HIVOX BIOTEK, INC.
K191898 07/16/2019 Sterile Latex Powder-Free Surgical Gloves Modern Healthcare Corp.
K041970 07/22/2004 BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML BIOTOP TECHNOLOGY CO., LTD.
K152034 07/22/2015 FS-PACS EC-WEB CO., LTD.
K042010 07/26/2004 POWER SCOOTER, MODEL TL-688 TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
K042012 07/26/2004 TEH LIN POWER SCOOTER, MODEL TL-822 TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
K042011 07/26/2004 POWER SCOOTER, MODEL TL0821 TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
K072067 07/27/2007 N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 SHUENN BAO SHING CORPORATION
K062218 08/01/2006 JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP JAN MAO INDUSTRIES CO., LTD.
K062238 08/02/2006 TYTAN BLOOD PRESSURE CUFF TYTAN MEDICAL CORP.
K062311 08/08/2006 KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 KARMA MEDICAL PRODUCTS CO., LTD.
K062309 08/08/2006 KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 KARMA MEDICAL PRODUCTS CO., LTD.
K092448 08/10/2009 HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 HIVOX BIOTEK, INC.
K022697 08/13/2002 TEH LIN JUPITER POWER CHAIR, MODEL TL-320 TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
K022698 08/13/2002 SCOOTER MARS SERIES, MODEL TL-588 TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
K072337 08/20/2007 WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A WU'S TECH CO., LTD.
K092581 08/21/2009 MITS DICOM GATEWAY AND IMAGE MANAGER MITSMED MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
K032669 08/28/2003 Y.E.S. POWERED WHEELCHAIR, MODEL T200 YEOU EIR SHUEN MACHINERY CO., LTD.
K052375 08/30/2005 ALILIFE STAND UP POWERED WHEELCHAIR, HC-300 ALILIFE TECHNOLOGICAL CO., LTD.
K062555 08/30/2006 EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G VISGENEER, INC.
K052397 08/31/2005 CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) LIFE-SHIELD PRODUCTS, INC
K162430 08/31/2016 UniStrip1 Generic Blood Glucose Test Strips OK BIOTECH CO., LTD.
K202506 08/31/2020 Karma Powered Wheelchair Karma Medical Products Co., Ltd.
K032747 09/04/2003 BIOTOP DJT-A SAFETY SYRINGE BIOTOP TECHNOLOGY CO., LTD.
K032767 09/05/2003 LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES LILY MEDICAL SUPPLIES CO., LTD.
K152599 09/11/2015 PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System OK BIOTECH CO., LTD.
K062740 09/13/2006 JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU JINDELL MEDICAL INSTRUMENTS CO., LTD.
K082722 09/17/2008 P & F POWER WHEELCHAIR, MODEL HC-500SB P&F BROTHER IND.,CORP
K062790 09/18/2006 WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E WU'S TECH CO., LTD.
K023148 09/20/2002 EPW POWERED WHEELCHAIR, GP-201 EMG TECHNOLOGY CO., LTD.
K092893 09/21/2009 TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES TYTAN MEDICAL CORP.
K082808 09/24/2008 IMAGESVR PACS JAGUAR TECHNOLOGY LIMITED
K072712 09/25/2007 COMFORT ELECTRIC SCOOTER, LY-EW408 COMFORT ORTHOPEDIC CO. LTD.
K072711 09/25/2007 COMFORT POWERED WHEELCHAIR, LY-EB 206 COMFORT ORTHOPEDIC CO. LTD.
K033032 09/26/2003 WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR WU'S TECH CO., LTD.
K062892 09/26/2006 EUKARE EUMED BIOTECHNOLOGY CO., LTD.
K062888 09/26/2006 MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 EMG TECHNOLOGY CO., LTD.
K052673 09/27/2005 KING I POWERED SCOOTER, MODEL CTL-11 KING I TECH CORPORATION
K062947 09/28/2006 HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES PENG LIM ENTERPRISE CO., LTD.
K042719 09/30/2004 HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 HOME HEALTH TECHNOLOGY CO., LTD.
K133111 09/30/2013 KINGTECH DIGITAL THERMOMETER KINGTECH ENTERPRISE, LTD.
K063026 10/02/2006 OK METER BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD.
K063032 10/03/2006 COMFORT SCOOTER, MODEL LY-EW415 COMFORT ORTHOPEDIC CO. LTD.
K063030 10/03/2006 COMFORT SCOOTER MODEL LY-EW406 COMFORT ORTHOPEDIC CO. LTD.
K082965 10/03/2008 DS-A BLOOD GLUCOSE MONITORING SYSTEM ALLIANCE INTERNATIONAL CO., LTD.
K042748 10/04/2004 GENEMAX POWER WHEELCHAIR, PW3 GENEMAX MEDICAL PRODUCTS INDUSTRY CORP.
K042749 10/04/2004 GENEMAX POWER WHEELCHAIR, PW4 GENEMAX MEDICAL PRODUCTS INDUSTRY CORP.
K072860 10/05/2007 YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 YA HORNG ELECTRONIC CO., LTD.
K033240 10/06/2003 BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 TUNG KENG ENTERPRISE CO., LTD.
K033239 10/06/2003 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 TUNG KENG ENTERPRISE CO., LTD.
K033241 10/06/2003 BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320 TUNG KENG ENTERPRISE CO., LTD.
K072905 10/11/2007 3TEST SUPREME GLUCOSE MONITORING SYSTEM NEUERO ENGINEERING INC.
K073044 10/29/2007 HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 HEARTWAY MEDICAL PRODUCTS CO., LTD.
K043376 12/08/2004 HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR HOME HEALTH TECHNOLOGY CO., LTD.
K014119 12/17/2001 WU'S 3-WHEELED NEO SCOOTER, WT-M3 WU'S TECH CO., LTD.
K063757 12/19/2006 MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES SHANGHAI MOTEX HEALTHCARE CO., LTD.
K024215 12/20/2002 ENERTRON CPR JACK ENERTRON ENGINEERING CO.
K043511 12/20/2004 SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 SOLEUS CHAMP INTERNATIONAL CO., LTD.
K014198 12/21/2001 BIOTECH B990K VIVI WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD.
K024325 12/26/2002 JI-EE ELECTRIC SCOOTER, ESTHETE ES 1 JI-EE INDUSTRY CO., LTD.
K024329 12/26/2002 JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3 JI-EE INDUSTRY CO., LTD.
K971930 05/27/1997 BK-N SEALING CAP BIOTRONIK, INC.


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