Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 30
- Latest Decision
- 2008-04-02
Clearances · page 15 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K072551 | LD-I 75 AND LD-I 200 | Meditech International, Inc. | NHN | Class II | 2008-04-02 |
| K080661 | MODELS TENS 7000, EMS 7500 AND TWIN STIM | Koalaty Products, Inc. | IPF | Class II | 2008-03-24 |
| K073361 | MUSCLE PAIN DEVICE (MPD) | Stevens Proof of Concept, Inc. | IPF | Class II | 2008-03-18 |
| K063175 | IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) | Medical Technology Systems, Inc. | MOC | Class II | 2008-03-14 |
| K071666 | SLENDERTONE ENERVIVE, MODEL 561 | Bio-Medical Research Corp. | NGX | Class II | 2008-03-12 |
| K072256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL | Hill Laboratories Co. | PFW | Class II | 2008-03-12 |
| K080207 | DANYANG HUAYI K2 AND K7 WHEELCHAIRS | Danyang Huayi Medical Supply & Equipment Co, Ltd. | IOR | Class I | 2008-03-12 |
| K080318 | ALMA LASER NIR MODULE | Alma Lasers , Ltd. | ILY | Class II | 2008-03-07 |
| K073276 | IONTOPHORESIS SYSTEM | Acclarent, Inc. | EGJ | Class II | 2008-03-05 |
| K073686 | C.T.M. POWER CHAIR, MODEL HS-1500 | C.T.M. Homecare Product, Inc. | ITI | Class II | 2008-02-27 |
| K080242 | HEARTWAY POWER MOBILITY SCOOTER, PF7 | Heartway Medical Products Co., Ltd. | INI | Class II | 2008-02-27 |
| K080288 | TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114 | Mega Motion, Inc. | INI | Class II | 2008-02-15 |
| K071596 | POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 | Nihon Seimitsu Sokki Co., Ltd. | IRP | Class II | 2008-02-15 |
| K080114 | HUAYI H035 BASIC WHEELCHAIR | Danyang Huayi Medical Supply & Equipment Co, Ltd. | IOR | Class I | 2008-02-15 |
| K073542 | CYCLETRAC CT-5000 | Pt Products, LLC | ITH | Class II | 2008-02-14 |
| K072534 | BIO-MAT 2000 | Richway Intl., Inc. | IRT | Class II | 2008-02-08 |
| K073110 | MERITS E600 SERIES STAIR LIFT | Merits Health Products Co., Ltd. | ILK | Class II | 2008-02-06 |
| K073521 | MUSMATE WALKING AID | Musmate, Ltd. | OHI | Class I | 2008-02-04 |
| K072252 | VEINOPLUS NEUROMUSCULAR STIMULATOR | Ad Rem Technology Sarl | IPF | Class II | 2008-01-30 |
| K073701 | DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000 | Dane Technologies | ITI | Class II | 2008-01-28 |
| K072174 | INSUCOZI INSULIN VIAL COVER | 41 Industries, LLC | IQG | Class I | 2008-01-25 |
| K072887 | G-TRAINER MEDICAL | Alter-G, Inc. | BXB | Class I | 2008-01-25 |
| K073512 | START JUNIOR | Otto Bock Healthcare LP | IOR | Class I | 2008-01-14 |
| K073513 | MERITS E700 PORCE LIFT | Merits Health Products Co., Ltd. | ING | Class II | 2008-01-14 |
| K072475 | BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) | Etac Sverige AB | IPL | Class II | 2007-12-21 |
| K072168 | OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 | Well-Life Healthcare Limited | NGX | Class II | 2007-12-19 |
| K072553 | SYSTEM-ARMS, MODEL 390,E60 | Bio-Medical Research, Ltd. | NGX | Class II | 2007-12-14 |
| K063642 | FD EMS, MODEL # D-FJ30E | Fuji Dynamics Limited | IPF | Class II | 2007-12-13 |
| K073044 | HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 | Heartway Medical Products Co., Ltd. | INI | Class II | 2007-12-07 |
| K071093 | SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 | San Shih Electrical Enterprise Co., Ltd. | IPF | Class II | 2007-12-06 |
| K072795 | MODELS EMS 5.0, EMS 5.1 | Koalaty Products, Inc. | IPF | Class II | 2007-11-27 |
| K072048 | LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE | Lynton Lasers Limited | ILY | Class II | 2007-11-16 |
| K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | Empi | EGJ | Class II | 2007-11-16 |
| K073134 | A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I | Invacare Corporation | ITI | Class II | 2007-11-16 |
| K070690 | THE LIFE VESSEL | Cottonwood Vessel Corporation | ILY | Class II | 2007-11-16 |
| K072712 | COMFORT ELECTRIC SCOOTER, LY-EW408 | Comfort Orthopedic Co., Ltd. | INI | Class II | 2007-10-31 |
| K072711 | COMFORT POWERED WHEELCHAIR, LY-EB 206 | Comfort Orthopedic Co., Ltd. | ITI | Class II | 2007-10-31 |
| K072620 | GAME READY CLASSIC SYSTEM, MODEL 550550 | Coolsystems, Inc. | IRP | Class II | 2007-10-31 |
| K071445 | TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS | Escada International, Inc. | ILY | Class II | 2007-10-29 |
| K072294 | SYSTEM-MINI, MODELS: 390, E30 | Bio-Medical Research, Ltd. | NGX | Class II | 2007-10-25 |
| K071347 | VAX-D GENESIS G2 SYSTEM | Vax-D Medical Technologies, LLC | ITH | Class II | 2007-10-05 |
| K072630 | FORU, MODEL EQ30 | Kwang Yang Motor Co., Ltd. | INI | Class II | 2007-10-03 |
| K071431 | GLOBUS GENESY 1100 STIMULATOR | Domino S.R.L. | IPF | Class II | 2007-09-21 |
| K072311 | TILITE AERO X | Tisport, LLC | IOR | Class I | 2007-09-21 |
| K072224 | ZIP'R PC | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | ITI | Class II | 2007-09-21 |
| K072337 | WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A | Wu'S Tech Co., Ltd. | INI | Class II | 2007-09-21 |
| K071650 | C350 POWERED WHEELCHAIR | Permobil AB | ITI | Class II | 2007-09-12 |
| K072153 | QUICKIE QX MANUAL FOLDING WHEELCHAIR | Sunrise Medical, Inc. | IOR | Class I | 2007-09-10 |
| K072152 | JUNIPER CLN1 DERMAL COOLING DEVICE | Juniper Medical, Inc. | ILO | Class II | 2007-09-07 |
| K070338 | RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS | Rainbow Communications, Inc. | ILY | Class II | 2007-08-28 |
| K072027 | FORU KV10HB | Kwang Yang Motor Co., Ltd. | ITI | Class II | 2007-08-20 |
| K072104 | HEARTWAY POWER MOBILITY SCOOTER, PF6 | Heartway Medical Products Co., Ltd. | INI | Class II | 2007-08-17 |
| K072165 | VICTORY THREE WHEEL SCOOTER, MODEL: SC610 | Pride Mobility Products Corp. | INI | Class II | 2007-08-17 |
| K071320 | EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 | Everlife Medical Equipment Co., Ltd. | IPF | Class II | 2007-08-17 |
| K063447 | INSIGHT DISCOVERY | Fasstech | IKN | Class II | 2007-08-16 |
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Johnson & Johnson Consumer Products, Inc. | IMD | Class I | 2007-08-14 |
| K071761 | LLOYD LINDEN, MODEL E04 | Lloyd Linden, Inc. | IPL | Class II | 2007-08-03 |
| K071793 | CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR | Barton Medical Corp. | INO | Class II | 2007-08-03 |
| K071949 | VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740 | Pride Mobility Products Corp. | INI | Class II | 2007-08-01 |
| K071137 | SONICATOR PLUS 940, MODEL ME940 | Mettler Electronics Corp. | IMG | Class II | 2007-08-01 |
| K071186 | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE | Ambu A/S | IKT | Class II | 2007-07-30 |
| K071444 | MECHANICAL WHEELCHAIR - L-FRAME SERIES | Colours 'N Motion | IOR | Class I | 2007-07-27 |
| K071282 | MODEL SEGAEGO 4D SCOOTER | Dalton Medical Corp. | INI | Class II | 2007-07-27 |
| K061914 | SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS | Sport-Elec S.A. | NGX | Class II | 2007-07-26 |
| K071284 | MODEL SEGAEGO 3D SCOOTER | Dalton Medical Corp. | INI | Class II | 2007-07-26 |
| K071390 | WHEELCHAIR MODEL STS | Innovative Products, Inc. | IPL | Class II | 2007-07-20 |
| K070516 | POWERLASER | Powermedic Aps | ILY | Class II | 2007-07-02 |
| K071050 | GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM | Coolsystems, Inc. | IRP | Class II | 2007-06-29 |
| K070672 | MASSAGE MATTRESS VM9100RM | Metek GmbH | JFB | Class II | 2007-06-26 |
| K070425 | VITALSTIM EXPERIA | Chattanooga Group | IPF | Class II | 2007-06-11 |
| K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | Oscor, Inc. | IKD | Class II | 2007-06-07 |
| K070931 | MODEL PMT850 | Promedtek, Inc. | ILX | Class II | 2007-05-24 |
| K070974 | LIGHT RELIEF, MODEL LR150, LR200 | Light Relief, LLC | ILY | Class II | 2007-05-24 |
| K071005 | HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 | Heartway Medical Products Co., Ltd. | ITI | Class II | 2007-05-22 |
| K071006 | HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 | Heartway Medical Products Co., Ltd. | ITI | Class II | 2007-05-21 |
| K070024 | THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE | Thor International | ILY | Class II | 2007-05-16 |
| K070427 | DUPEL TRANSPORT IONTOPHORESIS SYSTEM | Empi | EGJ | Class II | 2007-05-14 |
| K070318 | SKIPPI POWERED WHEELCHAIR FOR CHILDREN | Otto Bock Healthcare LP | ITI | Class II | 2007-05-11 |
| K071028 | VIEWMATE SYSTEM | Ep Medsystems | ITN | Class I | 2007-05-01 |
| K061632 | GLOBUS PREMIUM MUSCLE STIMULATOR | Domino S.R.L. | NGX | Class II | 2007-04-30 |
| K061849 | MESODERM | Aa Advanced Technology, Inc. | EGJ | Class II | 2007-04-30 |
| K063328 | IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) | Imc-Heart Way LLC | ITI | Class II | 2007-04-27 |
| K063745 | MEDILASER, MODEL 1000 | Laser Thera, LLC | ILY | Class II | 2007-04-23 |
| K071007 | HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 | Heartway Medical Products Co., Ltd. | INI | Class II | 2007-04-19 |
| K062453 | KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138 | Kingly Star Intl. Technology Co., Ltd. | IPF | Class II | 2007-04-17 |
| K070950 | LIFT CHAIR, MODEL C5 | Pride Mobility Products Corp. | INO | Class II | 2007-04-16 |
| K070802 | LERADOTECH, MODEL SC | Lerado China Limited | INI | Class II | 2007-04-13 |
| K070817 | LERADOTECH SCOOTER, MODEL SB | Lerado China Limited | INI | Class II | 2007-04-13 |
| K062631 | MYOMO E100 | Myomo, Inc. | OAL | Class II | 2007-04-12 |
| K063728 | TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Alfa Tech Medical Systems, Ltd. | IMG | Class II | 2007-04-04 |
| K070602 | C.T.M. MOBILITY SCOOTER# HS-265 | C.T.M. Homecare Product, Inc. | INI | Class II | 2007-04-02 |
| K070655 | WU'S POWERED WHEELCHAIR, MAMBO 36 | Wu'S Tech Co., Ltd. | ITI | Class II | 2007-04-02 |
| K070402 | MODIFICATION TO POLAR CARE 500 | Breg, Inc. | ILO | Class II | 2007-03-29 |
| K070493 | HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT | Heartway Medical Products Co., Ltd. | INI | Class II | 2007-03-23 |
| K070142 | SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 | Bio-Medical Research Corp. | NGX | Class II | 2007-03-23 |
| K070501 | RUIKE 3421 POWERED WHEELCHAIR | Shanghai Ruike Sports Goods Co., Ltd. | ITI | Class II | 2007-03-22 |
| K063568 | HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL | Suzhou Medical Appliance Factory | ILY | Class II | 2007-03-22 |
| K070603 | C.T.M. MOBILITTY SCOOTER # HS-295 | C.T.M. Homecare Product, Inc. | INI | Class II | 2007-03-20 |
| K070433 | LERADO, POWER WHEELCHAIR, PB | Lerado China Limited | ITI | Class II | 2007-03-16 |
| K070350 | P&F POWER WHEELCHAIR, HC-510 | P & F Brother Ind., Corp. | ITI | Class II | 2007-03-14 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.