meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
24
Latest Decision
2010-12-23

Clearances · page 13 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102134 MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM United Integrated Services Co., Ltd. ILY Class II 2010-12-23
K102910 MODEL LUNA MANUAL WHEELCHAIR P.D.G., Inc. IOR Class I 2010-12-23
K102837 HIROLLER ELEVATING WHEELCHAIR Max Mobility, LLC IPL Class II 2010-12-23
K102281 THERMAL MASSAGE BED, MODEL 2D-GX Inarex Corporation JFB Class II 2010-12-22
K102734 COMFORT STANDING WHEELCHAIR, HERO SERIES Comfort Orthopedic Co., Ltd. IPL Class II 2010-12-14
K102061 TREVAIR CHAIR ADULT Patmont Motor Werks, Inc. IOR Class I 2010-12-13
K101267 PREMIO 10 MOXA Sedatelec ILY Class II 2010-12-03
K102202 GS 3000 Emsi IPF Class II 2010-11-23
K102236 HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P D.T. Davis Enterprises Ltd. T/A Hovertech Int'L INK Class II 2010-11-18
K102110 24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN Foshan Shunde Jaeyong Hardware Co., Ltd. IOR Class I 2010-10-26
K102088 JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT Thyssenkrupp Ceteco Srl ING Class II 2010-10-20
K102031 GALAXY LITE Future Mobility Healthcare, Inc. IOR Class I 2010-10-20
K101859 REL-K ARTIFICAL LIMB PROSTHESIS Rizzoli Ortopedica S.P.A. ISY Class I 2010-10-13
K092973 DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE Bionen S.A.S. IKT Class II 2010-10-07
K100213 LUMANOSITY CELEBRITY, MODEL 204 Lumanosity, Inc. ILY Class II 2010-10-04
K102358 ZIP'R3/ ZIP'R3 XTRA SCOOTER Global Fabtech Wheelchair (Shanghai) Co., Ltd. INI Class II 2010-10-04
K102355 ZIP'R MANTIS POWERED WHEELCHAIR Global Fabtech Wheelchair (Shanghai) Co., Ltd. ITI Class II 2010-10-04
K102361 ZIP'R4/ ZIP'R4 XTRA SCOOTER Global Fabtech Wheelchair (Shanghai) Co., Ltd. INI Class II 2010-10-04
K101999 KAIYANG STEEL WHEELCHAIR Guangdong Kaiyang Medical Technology Co., Ltd. IOR Class I 2010-10-04
K101998 KAIYANG ALUMINUM WHEELCHAIR Guangdong Kaiyang Medical Technology Co., Ltd. IOR Class I 2010-10-04
K101611 RELAY POWER WHEELCHAIR Dalton Instrument Corp. ITI Class II 2010-09-29
K101524 C2000 POWERED WHEELCHAIR Otto Bock Healthcare LP ITI Class II 2010-09-29
K101889 DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE Pivotal Health Solutions ITH Class II 2010-08-27
K101719 TACAMO MANUAL WHEELCHAIR Dalton Instrument Corp. IOR Class I 2010-08-25
K093204 INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM Innovative Med, Inc. ILY Class II 2010-08-23
K102149 GAUNYING INFRARED LAMP Foshan Gaunying Electronics Co., Ltd. ILY Class II 2010-08-13
K093999 ARP POV SPORT Arp Manufacturing, Inc. NGX Class II 2010-08-10
K100556 SLENDERTONE FLEX MAX, MODEL 517 US Bio-Medical Research, Ltd. NGX Class II 2010-08-02
K101507 AMIGO CLASSIC FD Amigo Mobility Intl., Inc. INI Class II 2010-07-30
K101217 MAC-MOBILE AQUATIC CHAIR Rehamed Intl., LLC IOR Class I 2010-06-23
K101227 BACK-TEK York Biomedical, Inc. ILY Class II 2010-06-23
K101430 MLS-AC DERMA SCANNER Erchonia Corporation NHN Class II 2010-06-22
K092731 VIBRO-TRAC Pneumex, Inc. JFB Class II 2010-06-10
K100509 THL1 LASER Erchonia Corporation NHN Class II 2010-06-08
K101277 ORION II (HEAVY DUTY 350 LBS AND 500 LBS) Future Mobility Healthcare, Inc. IOR Class I 2010-06-04
K100656 COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) Wonjin Mulsan Co., Ltd. IRP Class II 2010-05-26
K101143 HEARTWAY POWER MOBILITY SCOOTER, S11 Heartway Medical Products Co., Ltd. INI Class II 2010-05-26
K101142 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 Heartway Medical Products Co., Ltd. INI Class II 2010-05-26
K100824 MECHANICAL WHEELCHAIR, MODEL DS 202-S Suzhou KD Medical IOR Class I 2010-05-25
K092476 SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M Sport-Elec NGX Class II 2010-05-07
K091615 MED CONTOUR General Project S.R.L. IMI Class II 2010-05-06
K100320 SLENDERTONE SYSTEM ULTRA MODEL E70/X70 Bio-Medical Research, Ltd. NGX Class II 2010-05-05
K100084 MULTI FRAME WHEELCHAIR R82 A/S IOR Class I 2010-04-12
K091791 PROVANT SYSTEM, MODEL 4201 Regenesis Biomedical, Inc. ILX Class II 2010-04-07
K100527 HOVEROUND TEKNIQUE, MODEL HD-6 Hoveround Corp. ITI Class II 2010-03-26
K094047 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR Modern Rehabilitation Solutions Co., Ltd. IOR Class I 2010-03-22
K093946 HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 Hoveround Corp. ILK Class II 2010-03-22
K100327 HEARTWAY POWER CHAIR, P23 Heartway Medical Products Co., Ltd. ITI Class II 2010-03-22
K100350 HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT Hoveround Corp. ITI Class II 2010-03-22
K092435 VERSEO AIR PRESSURE MASSAGER The American Export Group & International Services IRP Class II 2010-03-09
K093324 EMPI CONTINUUM Empi IPF Class II 2010-03-05
K091496 MEP-90 HAIR GROWTH STIMULATION SYSTEM Midwest Rf, LLC OAP Class II 2010-02-23
K093138 MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 Shenzhen Dongdixin Technology Co., Ltd. IPF Class II 2010-02-12
K090250 ELECTRO-LIGHT THERAPY Hill Laboratories Co. ILY Class II 2010-02-11
K092142 SPORT-ELEC BODY CONTROL SYSTEM BS Sport-Elec NGX Class II 2010-02-05
K100117 LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR Shenzhen Dongdixin Technology Co., Ltd. IPF Class II 2010-01-29
K092589 THERMOTEX PLATINUM SYSTEM Eas Consulting Group, LLC ILY Class II 2010-01-28
K093368 BUTTERFLY TONER MODEL GYM070 Global Marketing Partners Dba Gymmax USA NGX Class II 2010-01-27
K092627 CT2011 SONICSTIMU PAIN RELIEF DEVICE Shenzhen Dongdixin Technology Co., Ltd. IMG Class II 2010-01-14
K093825 AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE Ambu A/S IKT Class II 2010-01-13
K092791 KNEEHAB XP CONTROLLER, MODEL 411 Bio-Medical Research, Ltd. IPF Class II 2009-12-30
K092044 ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE Orthocor Medical ILX Class II 2009-12-18
K093259 ARP RX100 Arp Manufacturing, Inc. IPF Class II 2009-12-17
K091996 ORTHOCOR KNEE SYSTEM BASIC Orthocor Medical ILX Class II 2009-12-15
K091675 LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER Reimers and Janssen GmbH ILY Class II 2009-12-15
K092936 AMIGO ESCORT 7.5, MODEL 760001 PHS Amigo Mobility Intl., Inc. ITI Class II 2009-12-04
K091578 LIFT CHAIR, MODEL T3 Pride Mobility Products Corp. INO Class II 2009-12-02
K091248 MAXEMS, MODELS 1000 AND 2000 Bio Protech, Inc. IPF Class II 2009-11-30
K093100 REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) Shenzhen Comfort Technology Co., Ltd. IMC Class II 2009-11-24
K093499 HAIRMAX LASERCOMB Lexington International, LLC OAP Class II 2009-11-23
K091865 SPORT-ELEC BODY CONTROL SYSTEM Sport-Elec NGX Class II 2009-11-13
K090532 T.E.A.R. TECH3 Vision Quest Industries, Inc. IPF Class II 2009-11-13
K091726 NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 Usa Laser Biotech, Inc. ILY Class II 2009-10-28
K091000 KNEEKG Emovi LXJ Class II 2009-10-26
K092961 JAZZY FRONTIE Pride Mobility Products Corp. ITI Class II 2009-10-23
K090542 SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 Sun-Rain System Corp. IMI Class II 2009-10-23
K091833 GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. Gemore Technology Co, Ltd. NGX Class II 2009-10-16
K090008 TANDA RESTORE, MODEL PTSCS Pharos Life Corporation ILY Class II 2009-10-15
K092225 AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR Amylior, Inc. ITI Class II 2009-10-09
K092650 HEARTWAY POWER MOBILITY SCOOTER, S12 Heartway Medical Products Co., Ltd. INI Class II 2009-10-09
K091540 MTD 4000 Mettler Electronics Corp. ITH Class II 2009-10-08
K092130 RASCAL WE GO 250 POWERED WHEELCHAIR Electric Mobility, LLC ITI Class II 2009-09-21
K092155 HEARTWAY POWER MOBILITY SCOOTER, S8 Heartway Medical Products Co., Ltd. INI Class II 2009-09-21
K092154 HEARTWAY POWER MOBILITY SCOOTER, S9 Heartway Medical Products Co., Ltd. INI Class II 2009-09-21
K083679 UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 Uroval IKN Class II 2009-09-11
K092222 THERMAPULSE Palomar Medical Products, Inc. ILY Class II 2009-08-20
K091497 K-LASER K-1200, MODEL 12 W Eltech S.R.L ILY Class II 2009-08-19
K091410 DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, Spes Medica Srl IKT Class II 2009-08-11
K091158 SCALAR WAVE LASER SYSTEM Stellar Lasers ILY Class II 2009-08-10
K091285 AL T LASER, MODEL AVI HPLL-12 Avicenna Laser Technology, Inc. ILY Class II 2009-07-28
K083105 KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 Bio-Medical Research, Ltd. IPF Class II 2009-07-24
K092088 VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713 Pride Mobility Products Corp. INI Class II 2009-07-16
K083183 AKLARUS PHOTOTHERAPY SYSTEM Hill Laboratories Co. ILY Class II 2009-07-16
K081998 H-WAVE SPORT Electronic Waveform Laboratory, Inc. NGX Class II 2009-07-09
K091242 BANTAM Altimate Medical, Inc. INO Class II 2009-07-06
K091418 C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION C.T.M. Homecare Product, Inc. INI Class II 2009-07-06
K090256 POWER STANDING DANI Davismade, Inc. IPL Class II 2009-07-06
K091727 MEDICAL TREATMENT CHAIR, T400, T500,T600 Fresenius Medical Care South Asia Pacific Pty , Ltd. INO Class II 2009-07-06
K090735 C.T.M. MOBILITY SCOOTER, HS-528 C.T.M. Homecare Product, Inc. INI Class II 2009-07-06
K091482 HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 Danyang Huayi Medical Supply & Equipment Co, Ltd. IOR Class I 2009-07-06

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