meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
21
Latest Decision
2005-02-09

Clearances · page 18 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K041390 DIAMOND MEDISTIM Diamond Systems USA, Inc. IPF Class II 2005-02-09
K042719 HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 Home Health Technology Co., Ltd. ITI Class II 2005-02-03
K050087 LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800 Lerado Oversea Ltd. Twn Branch (Bvi) ITI Class II 2005-02-01
K042650 BIOMOVE 3000 Curatronic, Ltd. IPF Class II 2005-01-27
K043326 BEWELL, MODEL SC 20 Cycling and Health Tech. Industry R&D Center INI Class II 2005-01-26
K042596 LSA HELIUM Lifestand IPL Class II 2005-01-26
K034009 LAPEX 2000 Meridian Co., Ltd. NHN Class II 2005-01-21
K041920 INFINITY PLUS ELECTROTHERAPY SYSTEM Empi IPF Class II 2005-01-21
K043376 HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR Home Health Technology Co., Ltd. ITI Class II 2005-01-10
K043047 DYNATRON IBOX IONTOPHORESIS DEVICE Dynatronics Corp. EGJ Class II 2005-01-07
K030295 LTU-904 PORTABLE LASER THERAPY UNIT Riancorp Pty, Ltd. NZY Class II 2004-12-23
K043239 HEALTHSTAR ELITE Hill Laboratories Co. ITH Class II 2004-12-22
K041679 COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT Onyx Medical, Inc. ILY Class II 2004-12-16
K043332 WHEELCHAIR, MODEL 8500-II Cycling and Health Tech. Industry R&D Center IOR Class I 2004-12-13
K042532 BIOCARE SYSTEMS PREMIR 818 Biocare Systems, Inc. ILY Class II 2004-12-13
K041364 ML830 LASER SYSTEM Microlight Corporation of America ILY Class II 2004-12-13
K043069 HOVEROUND E100 POWER CHAIR Hoveround Corp. ITI Class II 2004-12-03
K042920 HOVEROUND SE-3 POWERCHAIR Hoveround Corp. ITI Class II 2004-12-03
K041063 SMARTWAVE MS 2000 Newwave Medical, LLC IPF Class II 2004-12-01
K030275 MB SYSTEM, BIOENERGY LIGHT THERAPY Amest Corp. ILY Class II 2004-11-29
K034005 SDS-4I Skylark Device & Systems Co., Ltd. IPF Class II 2004-11-18
K042881 PMD-2000 INTERFERENTIAL STIMULATOR Phoenix Medical Devices, LLC IPF Class II 2004-11-18
K042256 IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE Usa Laser Biotech, Inc. ILY Class II 2004-11-17
K042749 GENEMAX POWER WHEELCHAIR, PW4 Genemax Medical Products Industry Corp. ITI Class II 2004-11-12
K042748 GENEMAX POWER WHEELCHAIR, PW3 Genemax Medical Products Industry Corp. ITI Class II 2004-11-12
K042652 TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR Taiwan King Strong Co., Ltd. IOR Class I 2004-11-04
K042444 LITESTREAM 500E Pride Mobility Products Corp. IOR Class I 2004-10-21
K042104 AMERICAN BANTEX, MODEL MS 3 American Bantex Corp. INI Class II 2004-10-21
K042545 HOVEROUND MPV-5 POWERCHAIR Hoveround Corp. ITI Class II 2004-10-21
K042165 CUTERA TABLETOP AESTHETIC PRODUCT Cutera, Inc. ILY Class II 2004-10-18
K041530 EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 Stargate International, Inc. NHN Class II 2004-10-14
K042590 TRANSDERM IONTO SYSTEM, MK 2 Mattioli Engineering Corp. EGJ Class II 2004-10-14
K042554 AUTO THERM 390, MODEL ME 390 Mettler Electronics Corp. IMJ Class II 2004-10-08
K042764 MEDLINE STRIDER MIDI 4 Medline Industries, Inc. INI Class II 2004-10-08
K042401 VARI-ABLE APB (ADAPTABLE POSITIONING BASE) American Track Roadsters, Inc. IOR Class I 2004-10-07
K042763 MODIFICATION TO MEDLINE STRIDER MIDI 3 Medline Industries, Inc. INI Class II 2004-10-07
K042612 JAZZY 600 Pride Mobility Products Corp. ITI Class II 2004-10-06
K042535 ADVENTURE A10 Ulrich Alber GmbH ITI Class II 2004-10-05
K041210 POWERED WHEELCHAIR, MODEL B-600 Otto Bock Healthcare LP ITI Class II 2004-10-01
K040849 MENTAMOVE Cole & Associates IPF Class II 2004-10-01
K041208 POWERED WHEELCHAIR, MODEL B-500 Otto Bock Healthcare LP ITI Class II 2004-10-01
K041211 POWERED WHEELCHAIR, MODEL C-1000 Otto Bock Healthcare LP ITI Class II 2004-10-01
K041139 ERCHONIA EML LASER Erchonia Medical, Inc. NHN Class II 2004-09-30
K042033 HOVEROUND POWER WHEELCHAIR, MODEL HD700 Hoveround Corp. ITI Class II 2004-09-29
K031611 P4-FITNESS Valmed Corp. NGX Class II 2004-09-29
K042011 POWER SCOOTER, MODEL TL0821 Teh Lin Prosthetic & Orthopaedic, Inc. INI Class II 2004-09-24
K042012 TEH LIN POWER SCOOTER, MODEL TL-822 Teh Lin Prosthetic & Orthopaedic, Inc. INI Class II 2004-09-24
K041535 LSC LIFESTAND COMPACT Lifestand IPL Class II 2004-09-16
K041186 CADDY Afikim Electric Vehicles ITI Class II 2004-09-09
K041924 HAUSTED POWERTRAN SERIES STRETCHER STERIS Corporation INK Class II 2004-09-09
K042304 CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251 Spectris Technologies, Inc. IOR Class I 2004-09-08
K041346 SYNERGY ULTIMATE Pride Mobility Products Corp. ITI Class II 2004-09-08
K040662 VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS Chattanooga Group ILY Class II 2004-09-08
K042010 POWER SCOOTER, MODEL TL-688 Teh Lin Prosthetic & Orthopaedic, Inc. INI Class II 2004-09-01
K032954 ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 Danmeter A/S IPF Class II 2004-08-09
K041752 TEH LIN POWERED WHEELCHAIR, MDG-601 Teh Lin Prosthetic & Orthopaedic, Inc. ITI Class II 2004-08-05
K041677 KARMA SCOOTER, MODEL KS-747.2 Karma Medical Products Co., Ltd. INI Class II 2004-08-05
K041219 ELECTRO Permobil AB ITI Class II 2004-08-04
K040798 HES ULTRASONIC THERAPY APPLIANCE Hwang Sun Enterprise Co., Ltd. IMI Class II 2004-08-04
K040031 CERAGEM-C THERMAL ACUPRESSURE MASSAGER Ceragem Co., Ltd. JFB Class II 2004-07-28
K040754 AMERICAN BANTEX MS 4 MINI SCOOTER American Bantex Corp. INI Class II 2004-07-23
K031996 EXTENTRAC ELITE Advanced Back Technologies ITH Class II 2004-07-23
K041678 KARMA POWER WHEELCHAIR, MODEL KP-25 Karma Medical Products Co., Ltd. ITI Class II 2004-07-23
K041465 SINON SN-L402 LIGHTWEIGHT WHEELCHAIR Sinon Corporation IOR Class I 2004-07-23
K041336 PRO WALKER PL-200 POWER WHEELCHAIR Pro Walker, Inc. ITI Class II 2004-07-20
K040400 MYO-TRODE SG DISPOSABLE ELECTRODE Myotronics-Noromed, Inc. NUW Class II 2004-07-20
K041814 FS SERIES WHEELCHAIR Foshan Dongfang Medical Equipment Manufactory(Ltd) IOR Class I 2004-07-20
K041101 MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 Medical Adhesiveonline, LLC EGJ Class II 2004-07-07
K033174 BMLS03-3 Biomedical Life Systems, Inc. IPF Class II 2004-06-30
K041200 THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000 Migun Medical Instrument Co. , Ltd. JFB Class II 2004-06-17
K041146 CONTROL SOLUTIONS, INC., MODEL CS3102 HVG Control Solutions, Inc. IPF Class II 2004-06-08
K033819 INVACARE 3G TARSYS Invacare Corp. ITI Class II 2004-06-04
K041341 GOLDEN SPYDER, MODEL GS-300 Golden Technologies, Inc. ITI Class II 2004-06-03
K040729 SOLARIS D890 THERAPY PROBE Dynatronics Corp. ILY Class II 2004-06-02
K041337 PRO WALKER ML-300 FOLDABLE WHEELCHAIR Pro Walker, Inc. IOR Class I 2004-05-28
K040664 OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 Omnilight, Inc. ILY Class II 2004-05-28
K041055 MEDLINE STRIDER MAXI 4 Medline Industries, Inc. INI Class II 2004-05-25
K041053 MEDLINE STRIDER MICRO 3 Medline Industries, Inc. INI Class II 2004-05-25
K041187 A&I SCOOTER, SC-301 Well Success Biotech, Inc. INI Class II 2004-05-25
K041054 MEDLINE STRIDER MAXI 3 Medline Industries, Inc. INI Class II 2004-05-25
K041193 A&I SCOOTER, SC-402 Well Success Biotech, Inc. INI Class II 2004-05-25
K041190 A&I POWER WHEELCHAIR, PC-401 Well Success Biotech, Inc. ITI Class II 2004-05-25
K040677 COMBI SELF PROPELLED SHOWER COMMODE Kjaerulff Rehabilitation A/S IOR Class I 2004-05-20
K033142 POWERED WHEELCHAIR Nats Corp. ITI Class II 2004-05-19
K040457 NOMAD FROM DYNAMIS MOBILITY LTD. Dynamis Mobility , Ltd. ITI Class II 2004-05-19
K030869 BITESTRIP S.L.P. , Ltd. KZM Class II 2004-05-14
K041072 KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT Invacare Corporation IOR Class I 2004-05-12
K040818 MEDLINE STRIDER MINI 3 Medline Industries, Inc. INI Class II 2004-05-07
K040838 MEDLINE STRIDER MINI 4 Medline Industries, Inc. INI Class II 2004-05-07
K040317 IVC SYSTEM Mark H. Friedman ILO Class II 2004-05-07
K040679 RICH-MAR AUTOPRISM INFRARED LAMP Rich-Mar Corp. ILY Class II 2004-05-07
K040856 RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER Rapid Aid , Ltd. MPO Class I 2004-05-03
K041025 BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED Golden Technologies, Inc. INI Class II 2004-05-03
K040968 WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D Wu'S Tech Co., Ltd. INI Class II 2004-04-30
K040495 NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 Naimco, Inc. EGJ Class II 2004-04-22
K040622 FREEDOM HP Freedom Designs, Inc. IOR Class I 2004-04-16
K040285 VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER Chattanooga Group IMG Class II 2004-04-12
K031310 TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR Tai Sheng Electrical Machinery Co., Ltd. IPF Class II 2004-04-12
K033116 OPTI-RIDER DELUXE Hansung Econet Co., Ltd. INI Class II 2004-04-12
K040772 PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM Penner Manufacturing, Inc. ILJ Class II 2004-04-05

5,661 clearances in the Physical Medicine panel. Data: openFDA.