Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 26
- Latest Decision
- 2015-07-30
Clearances · page 10 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K151199 | SmartDrive Wheelchair Power Assist | Max Mobility, LLC | ITI | Class II | 2015-07-30 |
| K143737 | EM25 - glute toning device | Hivox Biotek, Inc. | NGX | Class II | 2015-07-27 |
| K143383 | Q6 Edge EM | Pride Mobility Product Corporation | ITI | Class II | 2015-07-23 |
| K150742 | Muscle Stimulation System 110 | Niveus Medical, Inc. | IPF | Class II | 2015-07-23 |
| K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | OAP | Class II | 2015-07-22 |
| K150574 | Modular Power Positioning System | Motion Concepts | ITI | Class II | 2015-06-30 |
| K142912 | Merits Yoga Power Scooter, S542 | Merits Health Products Co., Ltd. | INI | Class II | 2015-06-23 |
| K141919 | VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR | Ad Rem Technology Sarl | NGX | Class II | 2015-06-16 |
| K142783 | HEARTWAY Electrically Powered Wheelchair P27 | Heartway Medical Products Co., Ltd. | ITI | Class II | 2015-06-12 |
| K150548 | Tek RMD (Tek Robotic Mobilization Device) | Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S | IPL | Class II | 2015-06-11 |
| K150578 | Capillus 272 Office Pro | Capillus, LLC | OAP | Class II | 2015-06-09 |
| K142770 | Powered Wheelchair | Aat Alber Antriebstechnik GmbH | ITI | Class II | 2015-06-09 |
| K150466 | ZX2 Laser System | Lzr7, Inc. | ILY | Class II | 2015-06-08 |
| K142494 | ViMove | Dorsavi, Ltd. | IKN | Class II | 2015-05-28 |
| K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | MPO | Class I | 2015-05-27 |
| K150269 | Ballancer 505 System, Model 1201-AC | Mego Afek AC , Ltd. | IRP | Class II | 2015-05-26 |
| K150139 | Rachel's Remedy | Rachel'S Remedies, LLC | IMA | Class I | 2015-05-22 |
| K150453 | TULA Iontophoresis System with Earset | Acclarent, Inc. | EGJ | Class II | 2015-05-20 |
| K142055 | GYMFORM ABS & CORE | Well Brain International , Ltd. | NGX | Class II | 2015-05-11 |
| K142162 | MERITS TRANSFORMER POWER SCOOTER, S941 | Merits Health Products Co., Ltd. | INI | Class II | 2015-05-01 |
| K143101 | Helio A7 Manual Wheelchair, Move Manual Wheelchair | Motion Composites | IOR | Class I | 2015-05-01 |
| K143551 | Compex Wireless USA | Djo, LLC | NGX | Class II | 2015-04-28 |
| K143034 | Jintronix | Jintronix, Inc. | LXJ | Class II | 2015-04-22 |
| K150033 | Air Compressible Limb Therapy System | Daesung Maref Co., Ltd. | IRP | Class II | 2015-04-20 |
| K142824 | LX-100 Hair Growth Stimulation System | Hairlabs International, Inc. | OAP | Class II | 2015-04-14 |
| K133033 | HIDREX PSP1000 | Hidrex GmbH | EGJ | Class II | 2015-04-08 |
| K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator | Cymedica Orthopedics, Inc. | IPF | Class II | 2015-04-02 |
| K150175 | HeatLux Pro I | Home Skinovations , Ltd. | ILY | Class II | 2015-03-31 |
| K143180 | F3 | Permobil AB | ITI | Class II | 2015-03-27 |
| K143014 | F5 | Permobil AB | ITI | Class II | 2015-03-25 |
| K143207 | Revitive IX (OTC) | Actegy , Ltd. | NGX | Class II | 2015-03-23 |
| K143414 | Hill-Rom Wireless Connectivity Module | Hill-Rom | IOQ | Class II | 2015-03-10 |
| K142731 | HEARTWAY Electrically Powered Wheelchairs | Heartway Medical Products Co., Ltd. | ITI | Class II | 2015-02-27 |
| K150190 | IntraTemp Solution Warmer | Ecolab, Inc. | LHC | Class I | 2015-02-26 |
| K142228 | Heated Eye Pad | Digital Heat Corporation | IRT | Class II | 2015-02-09 |
| K143199 | Capillus 272 Pro | Capillus, LLC | OAP | Class II | 2015-01-29 |
| K141892 | QK-SYSTEMIC THERAPEUTIC APPARATUS | Harbin Quanke Medi-Technical Development Co., Ltd. | ILY | Class II | 2015-01-28 |
| K143059 | TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) | Tone-A-Matic International, Inc. | NGX | Class II | 2015-01-26 |
| K140706 | LEVO MAX | Levo AG | ITI | Class II | 2015-01-21 |
| K142025 | NEUROLUMEN PN-1000 | Neurolumen, LLC | ILY | Class II | 2015-01-21 |
| K141921 | HIVOX SPOPAD EMS | Hivox Biotek, Inc. | NGX | Class II | 2015-01-16 |
| K142722 | 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 | Livetec GmbH | ILY | Class II | 2015-01-13 |
| K141783 | TDX SP2 POWER WHEECHAIR | Invacare Corporation | ITI | Class II | 2015-01-09 |
| K141588 | NUTRA STIM HAIR LASER COMB | Nutra Luxe MD, LLC | OAP | Class II | 2015-01-08 |
| K141596 | NUTRA STIM HAIR LASER COMB | Nutra Luxe MD, LLC | OAP | Class II | 2015-01-08 |
| K133187 | FREERIDER FR1, models FR1-13, FR1-15, FR1-17 | Freerider Corp | INI | Class II | 2015-01-08 |
| K142256 | Applied BioPhotonics Phototherapy System ABPT1003 | Applied Biophotonics , Ltd. | ILY | Class II | 2015-01-07 |
| K141861 | HILTHERA 4.0 | Jeisys Medical, Inc. | ILY | Class II | 2015-01-07 |
| K142173 | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | Ecolab, Inc. | LHC | Class I | 2014-12-30 |
| K143197 | Nice1 | Nice Recovery Systems, LLC | IRP | Class II | 2014-12-23 |
| K142457 | Quickie, Zippie | Sunrise Medical (Us), LLC | ITI | Class II | 2014-12-18 |
| K140592 | CERAGEM AUTOMATIC THERMAL MASSAGER | Ceragem International, Inc. | JFB | Class II | 2014-12-17 |
| K141691 | GEN_3 | Free Wheelchair Mission | IOR | Class I | 2014-12-17 |
| K140931 | IGROW II HAIR GROWTH SYSTEM | Apira Science, Inc. | OAP | Class II | 2014-12-05 |
| K142340 | Infrared Therapy System | Beijing Huatai Healthcare Technology Co., Ltd. | ILY | Class II | 2014-12-02 |
| K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | OAP | Class II | 2014-12-01 |
| K142215 | Power Twin21-50/Power Twin21-100 | Livetec GmbH | ILY | Class II | 2014-11-07 |
| K142078 | VELASII THERAPY LASER SYSTEM | Aspen Laser Systems, LLC | ILY | Class II | 2014-10-30 |
| K133225 | E-FIT EF-1280 EMS MACHINE | Fit-Pro Kft , Ltd. | NGX | Class II | 2014-10-24 |
| K141564 | OPTON PRO | Zimmer Medizinsystems GmbH | ILY | Class II | 2014-10-24 |
| K140023 | ELEVATION | Pdg Product Design Group, Inc. | IOR | Class I | 2014-10-16 |
| K142027 | 888 WNLE POWERED WHEELCHAIR | Pihsiang Machinery Mfg. Co., Ltd. | ITI | Class II | 2014-10-07 |
| K140467 | FLEX-MT + | Emsi | IPF | Class II | 2014-10-07 |
| K140416 | TREKKER, TREKKER TRANSIT | Convaid Products, Inc. | IOR | Class I | 2014-09-17 |
| K131983 | ITRAC CERVICAL TRACTION SYSTEM | Pivotal Health Solutions | ITH | Class II | 2014-09-10 |
| K140865 | INFRARED HEATING DEVICE | Pro Medical Supplies, Inc. | ILY | Class II | 2014-09-03 |
| K132855 | HEARTWAY POWER MOBILITY SCOOTER | Heartway Medical Products Co., Ltd. | INI | Class II | 2014-08-29 |
| K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED | Ecolab, Inc. | LHC | Class I | 2014-08-28 |
| K140204 | JWX-2 | Yamaha Motor Co., Ltd. | ITI | Class II | 2014-08-28 |
| K133638 | GEKO | Firstkind Limited | IPF | Class II | 2014-08-21 |
| K141567 | IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM | Apira Science, Inc. | OAP | Class II | 2014-08-21 |
| K133981 | AVACEN 100 | Avacen, Inc. | IRT | Class II | 2014-08-15 |
| K130631 | BUZZY | Mmj Labs, LLC | PHW | Class I | 2014-08-13 |
| K133108 | FIT BELT | Hong Qiangxing (Shenzhen) Electronics Limited | NGX | Class II | 2014-08-05 |
| K131926 | THERMOPULSE | Ibramed Equipamentos Medicos | IMJ | Class II | 2014-07-24 |
| K132856 | HEARTWAY POWER WHEELCHAIR | Heartway Medical Products Co., Ltd. | ITI | Class II | 2014-07-15 |
| K131094 | VIMOVE | Dorsa VI Pty., Ltd. | IKN | Class II | 2014-07-11 |
| DEN130034 | REWALK | Argo Medical Technologies, Inc. | PHL | Class II | 2014-06-26 |
| K140519 | RECOVERY PUMP 737R | Mego Afek AC , Ltd. | IRP | Class II | 2014-06-16 |
| K133965 | OTC EMS STIMULATOR | Shenzhen Dongdixin Technology Co., Ltd. | NGX | Class II | 2014-06-16 |
| K131080 | PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE | Reimers and Janssen GmbH | ILY | Class II | 2014-06-13 |
| K132016 | LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM | Texas Applied Biomedical Services, Inc. | ILY | Class II | 2014-06-02 |
| K130017 | VALENTINE STEEL WHEELCHAIR | Valentine Intl. , Ltd. | IOR | Class I | 2014-05-28 |
| K140095 | PRIME ZOOM STRETCHER | Stryker Corporation | INK | Class II | 2014-05-20 |
| K134001 | FIREFLY | Firstkind Limited | NGX | Class II | 2014-05-15 |
| K132529 | GALLIEON-1 MEDICAL LASER | Future Device and Technology, Inc. | ILY | Class II | 2014-05-12 |
| DEN120016 | DEKA ARM SYSTEM | Deka Integrated Solutions Corporation | PAE | Class II | 2014-05-09 |
| K134017 | GIGALASER | Powermedic Aps | ILY | Class II | 2014-05-02 |
| K131917 | NEURODYN COMPACT, NEURODYN II | Ibramed Equipamentos Medicos | IPF | Class II | 2014-04-29 |
| K132179 | ARASYS | Ion Genius, Inc. | NGX | Class II | 2014-04-28 |
| K131660 | SMART (SMART-D, SMART-DX) | Bts S.P.A. | LXJ | Class II | 2014-04-17 |
| K132940 | ERCHONIA ALLAY | Erchonia Medical, Inc. | NHN | Class II | 2014-04-14 |
| K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM | Djo, LLC | IPF | Class II | 2014-04-10 |
| K131899 | SW-THERM | Shenzhen Dongdixin Technology Co., Ltd. | IMJ | Class II | 2014-03-14 |
| K133483 | PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE | Portable Therapeutix | IRP | Class II | 2014-03-11 |
| K121123 | BIOFUSIONARY BEBE | Rocky Mountain Biosystems, Inc. | IMJ | Class II | 2014-03-10 |
| K130982 | LERADO, POWER WHEELCHAIR | Lerado Global (Macao Commercial Offshore) Limited | ITI | Class II | 2014-02-28 |
| K130847 | JINTRONIX REHABILITATION SYSTEM (JRS) | Jintronix, Inc. | LXJ | Class II | 2014-02-28 |
| K130517 | EZ TRANSPORT CHAIR | Harris Medical, LLC | IOR | Class I | 2014-02-25 |
| K131909 | DALTON LIFT CHAIR | Dalton Instrument Corp. | INO | Class II | 2014-02-24 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.