meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
27
Latest Decision
2007-03-14

Clearances · page 16 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K063353 CTBOX CERVICAL/LUMBAR TRACTION Circular Traction Supply, Inc. ITH Class II 2007-03-14
K070489 HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT Heartway Medical Products Co., Ltd. ITI Class II 2007-03-14
K062792 ERCHONIA IOTO_240 Erchonia Medical, Inc. EGJ Class II 2007-03-01
K070176 MAXHEALTH MECHANICAL WHEELCHAIR, K1 Maxhealth Corp. IOR Class I 2007-03-01
K063465 CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE Iomed, Inc. EGJ Class II 2007-02-28
K070400 LC THERAPY, MODEL LCT-1000 Litecure, LLC ILY Class II 2007-02-28
K063320 ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13) Imc-Heart Way LLC ITI Class II 2007-02-27
K063307 ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R) Imc-Heart Way LLC ITI Class II 2007-02-27
K062256 HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM Hill Laboratories Co. IMI Class II 2007-02-26
K062437 DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED Technomed Europe IKT Class II 2007-02-16
K063203 ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) Imc-Heart Way LLC ITI Class II 2007-02-13
K062646 RUIKE, MODEL 3411 Shanghai Ruike Sports Goods Co., Ltd. INI Class II 2007-02-05
K063135 SONIC-STIM Naimco, Inc. IMG Class II 2007-02-05
K063521 NISSIN PEDIATRIC SERIES WHEELCHAIR Nissin Medical, Inc. INM Class I 2007-02-05
K070025 C.T.M. MOBILITY SCOOTER, MODEL HS-310 C.T.M. Homecare Product, Inc. INI Class II 2007-02-01
K063574 LUMINEX LL LASER SYSTEM Medical Laser Systems, Inc. NHN Class II 2007-01-29
K062354 VECTRA GENISYS VMS FR Encore Medical L.P. IPF Class II 2007-01-26
K063475 IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS) Imc-Heart Way LLC ITI Class II 2007-01-23
K063196 LANDLEX, MODEL S403X Besteam Technology, Inc. INI Class II 2007-01-23
K060305 HAIRMAX LASERCOMB Lexington International, LLC OAP Class II 2007-01-18
K063736 FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 Pdg Product Design Group, Inc. IOR Class I 2007-01-17
K062439 POWERTONE, MODEL PT-11 Johari Digital Healthcare , Ltd. NGX Class II 2007-01-08
K063474 ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) Imc-Heart Way LLC ITI Class II 2006-12-22
K062645 RUIKE, MODEL 3431 Shanghai Ruike Sports Goods Co., Ltd. INI Class II 2006-12-19
K062635 MODEL 2200 Clarimedex, Inc. ILY Class II 2006-12-19
K063034 AIR-FLEX WITH AUTO-DISTRACTION Hill Laboratories Co. JFB Class II 2006-12-14
K062676 RUIKE, MODEL 3331 Shanghai Ruike Sports Goods Co., Ltd. INI Class II 2006-12-14
K063180 ISECURE SYRINGE CARTRIDGE HOLDER Hospira, Inc. IQG Class I 2006-12-11
K063030 COMFORT SCOOTER MODEL LY-EW406 Comfort Orthopedic Co., Ltd. INI Class II 2006-12-04
K061726 LSC, MODEL 3 Lifestand IPL Class II 2006-12-04
K060792 ILLUMIMED Photoactif, LLC ILY Class II 2006-12-01
K063389 GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54 Pride Mobility Products Corp. INI Class II 2006-11-17
K053225 CELLU M6 KEYMODULE I Lpg One, Inc. ISA Class I 2006-11-06
K063162 GOLDEN LITEWAY Golden Technologies, Inc. INI Class II 2006-11-02
K062476 CERAGEM RH1 AUTOMATIC THERMAL MASSAGER Ceragem International, Inc. JFB Class II 2006-10-31
K062660 CATALYSY Ki Mobility, LLC IOR Class I 2006-10-24
K062888 MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 Emg Technology Co., Ltd. ITI Class II 2006-10-24
K063032 COMFORT SCOOTER, MODEL LY-EW415 Comfort Orthopedic Co., Ltd. INI Class II 2006-10-16
K062790 WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E Wu'S Tech Co., Ltd. INI Class II 2006-10-11
K062309 KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 Karma Medical Products Co., Ltd. IOR Class I 2006-10-10
K061614 TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS Escada International, Inc. ILY Class II 2006-10-06
K062311 KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 Karma Medical Products Co., Ltd. IOR Class I 2006-10-04
K060153 ACUMED LASER, MODEL 1000 Laser Thera, LLC ILY Class II 2006-09-29
K062701 QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR Sunrise Medical, Inc. ITI Class II 2006-09-25
K062402 EASYSTAND EVOLV Invacare Corp. INO Class II 2006-09-21
K053254 INFANT HEEL WARMER BY INTCO Shanghai Intco Medical Supply Co., Ltd. MPO Class I 2006-09-19
K062160 GO GO MINI, MODEL SC30 Pride Mobility Products Corp. INI Class II 2006-09-12
K062483 MINI POWER CHAIR, MODEL MN 5000 Line Ind.(Shanghai) Co., Ltd. ITI Class II 2006-09-08
K052492 AIRNERGY+STREAM Natural Energy Solutions AG ILY Class II 2006-09-05
K062218 JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP Jan Mao Industries Co., Ltd. IOR Class I 2006-08-16
K061810 COUGAR WHEELCHAIR R82 A/S IOR Class I 2006-08-07
K060936 PARAGOLFER Parabasetec, GmbH IPL Class II 2006-08-07
K053041 MED SCULPT General Project S.R.L. IMI Class II 2006-08-02
K061522 TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM Activatek, Inc. EGJ Class II 2006-08-01
K061912 FUSION Burke, Inc. INI Class II 2006-08-01
K061514 BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100 Bruno Independent Living Aids, Inc. ING Class II 2006-07-13
K060191 ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT Accelerated Care Plus Corp. ILY Class II 2006-07-12
K061693 FORYOU POWERED WHEELCHAIR, MODEL FC-100 Foryou Technology Co., Ltd. ITI Class II 2006-07-06
K061694 MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S Medcare Manufacturing, Inc. IOR Class I 2006-07-05
K061116 MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR Mobilife, LLC ITI Class II 2006-07-03
K060814 DYNATRON ION IONTOPHORESIS ELECTRODE Dynatronics Corp. EGJ Class II 2006-06-14
K061475 ASTROTILT MANUAL WHEELCHAIR Pdg Product Design Group, Inc. IOR Class I 2006-06-14
K061080 IR PRO 250 Lhasa Oms, Inc. ILY Class II 2006-06-14
K052934 DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM S.O.R. Internacional, S.A. IMI Class II 2006-06-12
K060735 DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM Axiom Worldwide, Inc. ITH Class II 2006-05-26
K061010 FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR Future Mobility Healthcare, Inc. IOR Class I 2006-05-23
K061273 7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L Nova Ortho-Med, Inc. IOR Class I 2006-05-23
K060926 TRIPOD Freedom Designs, Inc. IOR Class I 2006-05-19
K061186 FLIGHT Aero Innovative Research, Inc. IOR Class I 2006-05-12
K053546 SONICATOR 740, MODEL ME 740 Mettler Electronics Corp. IMI Class II 2006-05-04
K052771 SENSOR WALK Otto Bock Healthcare LP IQI Class I 2006-05-03
K053078 ERGOSELECT 100 K/P, ERGOSELECT 200 K/P Ergoline GmbH ISD Class II 2006-04-27
K060579 COMFORT/IO IONTOPHORESIS ELECTRODES Pepin Mfg., Inc. EGJ Class II 2006-04-20
K060697 TRAVEL PAL (MM-111B) /MEGA MOTION Mega Motion, Inc. INI Class II 2006-04-11
K060236 MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE Iomed, Inc. EGJ Class II 2006-03-31
K060298 PILL PHONE Vocel NXQ Class I 2006-03-29
K060134 APOLLO IR HEAT LAMP SYSTEM Apollo Physical Therapy Products International ILY Class II 2006-03-21
K060531 QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS Sunrise Medical ITI Class II 2006-03-17
K060582 INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR Invacare Corporation IOR Class I 2006-03-16
K060125 SONIC PALPOMETER Palpometer Systems, Inc. IKE Class I 2006-03-16
K053507 ELITE ELECTROMED L.I.T.E. 4/1 Elite Electromedical NHN Class II 2006-03-15
K051875 BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS Meditech International, Inc. ILY Class II 2006-03-13
K060251 WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100 Well Home Health Products Co. IOR Class I 2006-03-08
K060068 AVANTICARE, MODEL SA4021 Lerado China Limited INI Class II 2006-03-08
K060212 MERITS MODEL E SERIES LIFT CHAIRS Merits Health Products Co., Ltd. INO Class II 2006-03-07
K053223 TRITON/TRU-TRAC/TX/TRITON DTS TRACTION Chattanooga Group ITH Class II 2006-02-24
K060150 SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM Andante Medical Devices , Ltd. IRN Class II 2006-02-23
K053376 CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810 Chung Cheng Electric Heating Co., Ltd. ILY Class II 2006-02-16
K052204 THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER Tzora Active Systems , Ltd. INI Class II 2006-02-15
K060042 LANDLEX, MODEL P100X Besteam Technology, Inc. INI Class II 2006-02-14
K051961 WWMED, MODEL 401 Wong Way Corporation ILY Class II 2006-02-10
K053473 MAESTRO MDTL LASER SYSTEM Advanced Medical Technologies, Inc. ILY Class II 2006-02-03
K050668 GRT LITE, MODEL 8-A Grt Solutions, Inc. NHN Class II 2006-02-03
K052534 TACAHE Dalton Medical Corp. ITI Class II 2006-01-27
K051028 BREEZE Afikim Electric Vehicles INI Class II 2006-01-27
K052479 MBATH 1000 (60) Enneking Medical, Inc. ILJ Class II 2006-01-26
K053574 MEDLINE PEDIATRIC WHEELCHAIRS Medline Industries, Inc. IOR Class I 2006-01-25
K052453 TRACTION SYSTEM, DIGIT-TRAC 930 Ever Prosperous Instrument, Inc. ITH Class II 2006-01-13
K052548 UROK ROCKING WHEELCHAIR, MODEL 700-4XX Amg Medical, Inc. IOR Class I 2006-01-06
K053285 MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM Durtech System Corp. IPF Class II 2006-01-05

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