meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
26
Latest Decision
2012-06-19

Clearances · page 12 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K113668 HEALITE II SYSTEM Lutronic Corporation ILY Class II 2012-06-19
K121487 LITECURE THERAPY COMPACT Litecure, LLC ILY Class II 2012-06-12
K120604 K-LASER Eltech S.R.L ILY Class II 2012-05-25
K111941 CHOYANG THERMAL MASSAGER Choyang Medical Instrument Co., Ltd. JFB Class II 2012-05-25
K111476 CONTOUR TECHNOLOGY MUSCLE STIMULATOR Contour Technology NGX Class II 2012-05-23
K112494 VARAYA AR , VARAYA SPORT Varaya Photoceuticals, LLC ILY Class II 2012-05-16
K120077 COMED K-SERIES MANUAL WHEELCHAIR Danyang Comed Healthcare Co., Ltd. IOR Class I 2012-05-14
K120166 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM Won Industrial Co. IRP Class II 2012-05-14
K113577 MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR Merits Health Products Co., Ltd. ITI Class II 2012-05-08
K113713 GEN_2 MECHANICAL WHEELCHAIR Free Wheelchair Mission IOR Class I 2012-05-07
K120171 ACCUSONIC ADVANTAGE Metron Medical Australia, Pty, Ltd. IMI Class II 2012-05-04
K112148 POWERED MUSCLE STIMULATOR Valmed, SA IPF Class II 2012-04-30
K113488 JAZZY ELITE 6 Pride Mobility Product Corporration ITI Class II 2012-04-18
K112816 ZHENJIANG ASURE MECHANICAL WHEELCHAIR Zhenjiang Assure Medical Equipment Co., Ltd. IOR Class I 2012-04-18
K120032 MECHANICAL WHEELCHAIR Aikin Healthcare Co., Ltd. IOR Class I 2012-04-13
K113463 POWER WHEELCHAIR Suzhou KD Medical Appliance Co., Ltd. ITI Class II 2012-04-06
K113677 GRINDCARE MEASURE Medotech A/S KZM Class II 2012-04-05
K111636 REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM Gunnell, Inc. IOR Class I 2012-04-03
K112948 JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR Jiangsu Healthy Way Medical Equipment Co;Ltd IOR Class I 2012-03-28
K112950 JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR Jiangsu Healthy Medical Equipment Co;Ltd IOR Class I 2012-03-28
K120526 YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. IOR Class I 2012-03-08
K112547 NEO NEST Denovo Proucts, LLC IMD Class I 2012-03-06
K120254 THERASAGE HEATING PAD Therasage Corporation ILY Class II 2012-03-06
K113097 LASER HELMET Theradome, Inc. OAP Class II 2012-03-02
K111341 CLEANE / CLEANE POP Medicon Co., Ltd. OZC Class II 2012-02-29
K112815 QUANTUM BARIATRIC 451 Pride Mobility Product Corporration ITI Class II 2012-02-29
K113231 WARP10,WARP75 Quantum Devices, Inc. ILY Class II 2012-02-27
K113275 COMPRESSIBLE LIMB THERAPY SYSTEM Wonjin Mulsan Co., Ltd. IRP Class II 2012-02-27
K113065 RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS Bella Elevator, LLC ING Class II 2012-02-22
K112016 L-SER KO LAMP Ya-Man, Ltd. ILY Class II 2012-02-10
K113250 DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE Dynatronics Corp. ILY Class II 2012-02-09
K113074 CMAP PRO Medical Technologies, Inc. IKN Class II 2012-02-02
K112074 EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 Everyway Medical Instruments Co.,Ltd ITH Class II 2012-02-01
K113308 BRUNO ELAN STAIRWAY ELEVATOR Bruno Independent Living Aids, Inc. ILK Class II 2012-02-01
K112348 RS-4I MUSCLE STIMULATOR Rs Medical IPF Class II 2012-01-19
K112441 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM Daesung Maref Co., Ltd. IRP Class II 2012-01-17
K112890 NORMATEC MVP NormaTec Industries, LP IRP Class II 2012-01-04
K112944 FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES Fresenius Medical Care South Asia Pacific Pty , Ltd. INO Class II 2011-12-30
K112479 DSJ MASSAGER Mego Afek AC , Ltd. IRP Class II 2011-12-07
K111901 ASA 'MPHI FAMILY DIODE LASER Cynosure, Inc. ILY Class II 2011-11-09
K111273 FIR HEAT THERAPHY SYSYEMS Shenzhen Anpan Technology Co., Ltd. IRT Class II 2011-11-08
K111858 LIFTKAR PT Sano Transportgeraete GmbH ILK Class II 2011-11-04
K102524 FUTURA Dr. Oliver Wenker, M.D., M.B.A. IMG Class II 2011-11-03
K110057 MINI MASSEUSE Mj Specialty Retail NGX Class II 2011-10-28
K112520 US-101L, US-103S Ito Co., Ltd. IMI Class II 2011-10-26
K110165 FREERIDER MODEL LUGGIE MODEL 168-4IT Freerider Luggie Scooters, Inc. INI Class II 2011-09-30
K112524 HAIRMAX LASERCOMB Lexington International, LLC OAP Class II 2011-09-26
K102938 ACQPOINT THERMAJADE MASSAGE TABLE Acqpoint, Inc. JFB Class II 2011-09-23
K111279 NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM Zynex Medical, Inc. IPF Class II 2011-09-20
K112502 PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 Hill-Rom Co. INK Class II 2011-09-19
K111278 Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE Otto Bock Healthcare LP ITI Class II 2011-09-16
K111329 NM-7000 Nuga Medical Co., Ltd. JFB Class II 2011-09-06
K102933 GEM-TONE BODY TRAINING SYSTEM Gemore Technology Co, Ltd. NGX Class II 2011-09-02
K111482 SONICATOR PLUS 920 Mettler Electronics Corp. IMG Class II 2011-08-25
K102926 GEMORE MUSCLE CONDITIONER; Gemore Technology Co, Ltd. NGX Class II 2011-08-25
K110342 YOLO CURVE Yolo Medical, Inc. ILY Class II 2011-08-22
K111714 HAIRMAX DUAL 12 Lexington International, LLC OAP Class II 2011-08-16
K112034 TECA ELITE DISPOSABLE CONCENTRIC NEEDLES Carefusion 209, Inc. IKT Class II 2011-08-12
K111739 KIDS ROCK 3 CHAIR Pride Mobility Products Corp. IOR Class I 2011-08-12
K111095 BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025 Electro Kinetic Technologies, LLC ITI Class II 2011-08-03
K111045 CENTRO FAMILY OF MANUAL WHEELCHAIRS Otto Bock Healthcare LP IOR Class I 2011-07-15
K110994 PARKER 500 Arjohuntleigh, Inc. ILJ Class II 2011-07-06
K102786 WELL-LIFE OTC EMS SYSTEM Well-Life Healthcare Limited NGX Class II 2011-07-01
K111131 TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES Carefusion 209, Inc. IKT Class II 2011-06-17
K110636 TULA IONTOPHORESIS SYSTEM Acclarent, Inc. EGJ Class II 2011-06-16
K103738 H-WAVE Electronic Waveform Laboratory, Inc. IPF Class II 2011-06-01
K110233 HAIRMAX LASERCOMB Lexington International, LLC OAP Class II 2011-05-27
K110495 LIFTKAR PT Sano Transportgerate GmbH ING Class II 2011-05-20
K103771 LOTUS BLAKE ESTEEM SCOOTER Letrix Power Hangzhou Pty, Ltd. INI Class II 2011-05-06
K110788 INNOVA WHEELCHAIR Columbia Medical Manufacturing, LLC IOR Class I 2011-05-06
K110985 ICON ADULT MANUAL Icon Wheelchairs, Inc. IOR Class I 2011-05-03
K110567 C.T.M. MOBILITY SCOOTER HS515(3W) C.T.M. Homecare Product, Inc. INI Class II 2011-04-22
K110395 C.T.M. MOBILITY SCOOTER - MODEL HS 118 C.T.M. Homecare Product, Inc. INI Class II 2011-04-22
K110671 WINCO STRETCHAIR Winco Mfg., LLC INK Class II 2011-04-22
K100862 BODYFLOW P2CH Physiomed Elektromedizin AG IPF Class II 2011-04-21
K103549 DENOVO TEDDY GEL INFANT HEEL WARMER Denovo Products, LLC MPO Class I 2011-04-08
K103368 HAIRMAX LASERCOMB Lexington International, LLC OAP Class II 2011-04-06
K103248 INTEGRITY SPINAL CARE SYSTEM Integra Life Sciences ITH Class II 2011-04-05
K110721 GAUNYING INFRARED LAMP Foshan Gaunying Electronics Co., Ltd. ILY Class II 2011-03-30
K110036 FX 222-02 POWERED WHEELCHAIR Lanzhou Wanli Aviation Electromechanical, Inc. ITI Class II 2011-03-28
K102190 WINSTIM Johari Digital Healthcare , Ltd. IMG Class II 2011-03-17
K102610 FOCUS EMG DEVICE Teleemg, LLC USA IKN Class II 2011-03-04
K102320 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) Daesung Maref Co., Ltd. IRP Class II 2011-03-04
K103477 PERMOBIL M300 / M400 Permobil AB ITI Class II 2011-03-03
K102375 LUCIA Meridian Co., Ltd. ILY Class II 2011-02-25
K102295 X2ABS DUAL CHANNEL FITNESS BELT Leto Enterprises Incorporation NGX Class II 2011-02-18
K101893 NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS Usa Laser Biotech, Inc. ILY Class II 2011-02-17
K092202 ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT Eswallow USA IPF Class II 2011-02-10
K103009 SENTICARE PILLSTATION Senticare, Inc. NXQ Class I 2011-01-28
K102319 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008 Won Industrial Co. IRP Class II 2011-01-28
K110048 CERSR ELECTROMYOGRAPHY SYSTEM Spinematrix, Inc. IKN Class II 2011-01-26
K103511 LITECURE THERAPY SYSTEM Litecure, LLC ILY Class II 2011-01-25
K101894 HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT Bioremedi Therapeutic Systems, Inc. ILY Class II 2011-01-21
K101716 HVR PAIN RELIEF DEVICE H.V.R., Inc. ILY Class II 2011-01-11
K102304 BREEZE C MODEL C (3W), BREEZE C (4W) Afikim Electric Vehicles INI Class II 2011-01-07
K101693 GAUNYING INFRARED LAMP MODEL IL50 Foshan Gaunying Electronics Co., Ltd. ILY Class II 2011-01-05
K103073 SUPER CHAIR FOR KIDS BY ORION Future Mobility Healthcare, Inc. IOR Class I 2011-01-03
K103212 ROUGHRIDER Whirlwind Wheelchair International IOR Class I 2011-01-03
K103122 C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG Aat Alber Antriebstechnik GmbH ILK Class II 2010-12-30
K101723 COMPACT WHEELCHAIR PLATFORM Design Specific Fletcher INO Class II 2010-12-23

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