Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 30
- Latest Decision
- 2009-07-06
Clearances · page 14 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K091723 | FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5 | Freedom Sciences, LLC | ITI | Class II | 2009-07-06 |
| K091858 | PINNACLE STAIR WAY LIFT | Summit Harmar, LLC | ILK | Class II | 2009-07-01 |
| K091881 | RPL/CPL VERTICAL PLATFORM LIFTS | Harmar Summit, LLC | ING | Class II | 2009-07-01 |
| K091056 | RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R | Rhythmlink International, LLC | IKT | Class II | 2009-06-23 |
| K091055 | RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R | Rhythmlink International, LLC | IKT | Class II | 2009-06-23 |
| K083580 | ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 | Led Intellectual Properties, LLC | ILY | Class II | 2009-06-22 |
| K091478 | TREVAIR CHAIR | Patmont Motor Werks, Inc. | IOR | Class I | 2009-06-18 |
| K081720 | PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS | Prime Herbs Corporation | ILY | Class II | 2009-06-16 |
| K083016 | ACTHYDERM | Microlab Americas, Inc. | EGJ | Class II | 2009-06-16 |
| K083008 | COOLSKIN | Elbio Co., Ltd. | ILO | Class II | 2009-06-10 |
| K090632 | COMPEX REHAB | Chattanooga Group | IPF | Class II | 2009-06-01 |
| K091212 | WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H | Wu'S Tech Co., Ltd. | INI | Class II | 2009-05-27 |
| K090856 | JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) | Thyssenkrupp Ceteco Srl | ING | Class II | 2009-05-27 |
| K091326 | ACTIVAPATCH | Activatek, Inc. | EGJ | Class II | 2009-05-27 |
| K090966 | AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) | Svrc Industries, Inc. | INI | Class II | 2009-05-15 |
| K082686 | MULTI-CHANNEL LASER THERAPY SYSTEM | United Integrated Services Co., Ltd. | ILY | Class II | 2009-05-11 |
| K091113 | MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V | Pride Mobility Products Corp. | INI | Class II | 2009-05-11 |
| K091043 | POWER DRIVE CHAIR, MODEL: TMM6 | Transmotion Medical, Inc. | INK | Class II | 2009-05-11 |
| K082223 | NEUTROLUMENPN SYSTEM, MODEL 1000 | Neurolumen, LLC | ILY | Class II | 2009-04-21 |
| K083595 | EZLASE | Biolase Technology, Inc. | ILY | Class II | 2009-04-14 |
| K090350 | EXTREME 4X4-X8 POWER WHEELCHAIR | Vestil Manufacturing Corp. | ITI | Class II | 2009-04-10 |
| K082951 | IMMERSION HYDROBATH | Arjo Hospital Equipment AB | ILJ | Class II | 2009-04-08 |
| K090805 | V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710 | Pride Mobility Products Corp. | INI | Class II | 2009-04-03 |
| K081166 | LIGHTSTREAM LOW LEVEL LASER | Solica Corporation | NHN | Class II | 2009-04-03 |
| K080950 | STIWELL MED4 | Otto Bock, Austria GmbH | IPF | Class II | 2009-04-02 |
| K090108 | HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR | Hoveround Corp. | ITI | Class II | 2009-03-19 |
| K090524 | GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV | Pride Mobility Products Corp. | INI | Class II | 2009-03-19 |
| K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 | Chattanooga Group | IMJ | Class II | 2009-03-18 |
| K083140 | COMPEX SPORT PLUS | Chattanooga Group | NGX | Class II | 2009-02-09 |
| K082927 | BIOEMG III | Bio-Research Associates, Inc. | KZM | Class II | 2009-02-06 |
| K073565 | STANDARD WHEELCHAIR PLATFORM | Design Specific , Ltd. | INO | Class II | 2009-02-06 |
| K080513 | QLASER SYSTEM | 2035, Inc. | NHN | Class II | 2009-01-30 |
| K083847 | MARVEL PEDIATRIC WHEELCHAIR | Rogue Wheelchairs, Inc. | IOR | Class I | 2009-01-30 |
| K083303 | LANDLEX, MODEL: 402X | Besteam Technology, Inc. | INI | Class II | 2009-01-26 |
| K083231 | PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT | Panthera Production AB | IOR | Class I | 2009-01-26 |
| K080134 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) | Wonjin Mulsan Co., Ltd. | IRP | Class II | 2009-01-23 |
| K083417 | INTRATEMP SOLUTION WARMER | C Change Surgical, LLC | LHC | Class I | 2009-01-13 |
| K082857 | RENEGADE WHEELCHAIR | Alpha One | IQC | Class II | 2009-01-06 |
| K081962 | LAPEX BCS | Meridian Co., Ltd. | ILY | Class II | 2008-12-29 |
| K083249 | QUICKIE RHYTHM | Sunrise Medical Hhg, Inc. | ITI | Class II | 2008-12-23 |
| K081355 | BIOFLEX LD-R100 TREATMENT HEAD | Meditech International, Inc. | ILY | Class II | 2008-12-18 |
| K083164 | SYSTEM-ARMS, MODELS 390, X60 | Bio-Medical Research, Ltd. | NGX | Class II | 2008-12-16 |
| K082970 | MARVEL WHEELCHAIR, MODEL EDCAL01 | Rogue Wheels, Inc. | IOR | Class I | 2008-12-12 |
| K083044 | HUBANG, MODEL HBL13/HBG12-S | Shanghai Hubang Medical Appliances Co., Ltd. | IOR | Class I | 2008-12-12 |
| K083560 | EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X | Lighthouse Technical Innovations, Inc. | ILY | Class II | 2008-12-11 |
| K070541 | IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II | Ivivi Technologies, Inc. | ILX | Class II | 2008-12-11 |
| K073681 | NANOBEAM 940, MODEL 940-900-02 | Davaray, Inc. | ILY | Class II | 2008-12-09 |
| K082963 | WU'S 4-WHEELED NEO SCOOTER, WT-M3A | Wu'S Tech Co., Ltd. | INI | Class II | 2008-11-24 |
| K081505 | THERAGEM PROFESSIONAL T1002 | Medica Health, Ltd. | ILY | Class II | 2008-11-19 |
| K073689 | LEP2000 THERAPY SYSTEM | International Medical Instruments, Inc. | NHN | Class II | 2008-11-13 |
| K081570 | DPL THERAPY SYSTEM | Led Technologies, LLC | ILY | Class II | 2008-11-07 |
| K081026 | BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 | Sport-Elec S.A. | NGX | Class II | 2008-11-05 |
| K082900 | KYMCO FORU, MODEL EQ10 | Kwang Yang Motor Co., Ltd. | INI | Class II | 2008-10-28 |
| K082722 | P & F POWER WHEELCHAIR, MODEL HC-500SB | P & F Brother Ind., Corp. | ITI | Class II | 2008-10-28 |
| K082901 | KYMCO FORU, MODEL EQ20 | Kwang Yang Motor Co., Ltd. | INI | Class II | 2008-10-28 |
| K082314 | BRAVORACER PEDIATRIC MANUAL WHEELCHAIR | Otto Bock Healthcare LP | IOR | Class I | 2008-10-28 |
| K083017 | LEVO C3 | Levo AG | IPL | Class II | 2008-10-24 |
| K082969 | LUMINEX INFRARED LAMP SYSTEM | Medical Laser Systems, Inc. | ILY | Class II | 2008-10-23 |
| K081053 | PIVOT ASSIST | Pivot Assist, LLC | INO | Class II | 2008-10-09 |
| K082784 | JUMAO MANUAL WHEELCHAIR | Danyang Jumao Healthcare Equipment Co., Ltd. | IOR | Class I | 2008-10-07 |
| K080786 | ML830TP | Microlight Corporation of America | ILY | Class II | 2008-10-03 |
| K082707 | MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER | Medx Electronics, Inc. | ILY | Class II | 2008-10-01 |
| K082087 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | IMD | Class I | 2008-09-11 |
| K082246 | DIGNITY 100 | Dignity Medical Devices, Inc. | IOR | Class I | 2008-09-09 |
| K080554 | INAREX, MODEL 2D-LX | Inarex Corporation | JFB | Class II | 2008-08-27 |
| K081247 | TM-400 | Ito Co., Ltd. | ITH | Class II | 2008-08-25 |
| K081075 | PAINSHIELD MD | Nano Vibronix , Ltd. | PFW | Class II | 2008-08-22 |
| K080102 | TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM | Escada International, Inc. | ILY | Class II | 2008-08-20 |
| K082274 | HAIDA MODEL HD11 MANUAL WHEELCHAIR | Jiangyin East China Medical Technology Co., Ltd. | IOR | Class I | 2008-08-19 |
| K082288 | HAIDA HD21 | Jiangyin East China Medical Technology Co., Ltd. | ITI | Class II | 2008-08-19 |
| K080533 | WINCO MODEL POWER SERIES LIFT CHAIR | Winco, Inc. | INO | Class II | 2008-08-11 |
| K073352 | WEBERNEEDLE BASIC LASER | Weber Medical GmbH | ILY | Class II | 2008-08-11 |
| K081980 | KYMCO FORU, MODEL EQ35 | Besteam Technology, Inc. | INI | Class II | 2008-08-04 |
| K081964 | K450 POWERED WHEELCHAIR | Permobil AB | ITI | Class II | 2008-07-29 |
| K080545 | ACTITRAINER | Actigraph, LLC | ISD | Class II | 2008-07-24 |
| K080465 | WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES | Ws Far IR Medical Technology Co., Ltd. | ILY | Class II | 2008-07-18 |
| K080914 | ULTRASHARP CONCENTRIC NEEDLES | Rochester Electro Medical, Inc. | IKT | Class II | 2008-07-15 |
| K071677 | SRT II MUSCLE STIMULATOR | Therapeutic Innovations, Inc. | IPF | Class II | 2008-07-11 |
| K073555 | INSULIN PROTECTOR | Medicool, Inc. | IQG | Class I | 2008-07-11 |
| K080689 | SPECTRA THERAPY SYSTEM A1000 LASER DEVICE | Premier Dynamics, Inc. | ILY | Class II | 2008-07-09 |
| K070888 | COMBI 8 MAX | Cec Electronica S.R.L. | IPF | Class II | 2008-07-03 |
| K081665 | MILLENIUM II | Next Mobility, LLC | IOR | Class I | 2008-06-27 |
| K080816 | VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT | Visual Footcare Technologies, LLC | OIZ | Class I | 2008-06-24 |
| K073330 | FREEDOM SCIENCES MOTION CONTROL MODULE (MCM) | Freedom Sciences, LLC | ITI | Class II | 2008-06-20 |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | Axelgaard Mfg. Co., Ltd. | EGJ | Class II | 2008-06-18 |
| K080609 | SWC/DWC WARMING CABINETS | Mac Medical | LHC | Class I | 2008-06-13 |
| K081133 | KYMCO FORU, MODEL EQ40 | Kwang Yang Motor Co., Ltd. | INI | Class II | 2008-06-10 |
| K080506 | MARTIN CHAIR, MODEL C4S1 | Martin Manufacturing Co., LLC | IOR | Class I | 2008-06-09 |
| K072399 | DEL SOL RED LIGHT THERAPY SYSTEM | Edge Systems, Inc. | ILY | Class II | 2008-05-23 |
| K073415 | NEMUS SYSTEM; NEMUS PC PERIPHERAL | Eb Neuro S.P.A. | IKN | Class II | 2008-05-23 |
| K080385 | CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR | E1 Ent., Inc. | ITI | Class II | 2008-05-13 |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | Gaymar Industries, Inc. | ILO | Class II | 2008-05-08 |
| K072206 | ERCHONIA EML LASER | Erchonia Medical, Inc. | NHN | Class II | 2008-04-24 |
| K072064 | GRAVILAX TRACTION SYSTEM | Therapeutic Clinical Technologies, Inc. | ITH | Class II | 2008-04-21 |
| K080084 | CELL GEN LASER, MODEL CG-4000 | Cell Gen Therapeutics, LLC | ILY | Class II | 2008-04-21 |
| K080787 | BIOMOVE 5000 SYSTEM | Curatronic, Ltd. | IPF | Class II | 2008-04-17 |
| K080270 | MANUAL RIGID MOBILITY WHEELCHAIR | Freedom Designs, Inc. | IOR | Class I | 2008-04-16 |
| K080373 | TACAHE PC1350 POWER WHEELCHAIR | Dalton Medical Corp. | ITI | Class II | 2008-04-14 |
| K080880 | RTM AND OVAL | Next Mobility, LLC | IOR | Class I | 2008-04-09 |
| K073132 | MODEL D DISC FORCE | North American Medical Corp (Nam) | ITH | Class II | 2008-04-03 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.