Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 26
- Latest Decision
- 2017-01-11
Clearances · page 9 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K160178 | Lympha-Flow(LF1200) | Daesung Maref Co., Ltd. | IRP | Class II | 2017-01-11 |
| K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | ILY | Class II | 2017-01-05 |
| K162686 | Kuschall Champion Manual Wheelchair | Invacare Corporation | IOR | Class I | 2016-12-28 |
| K162692 | Kuschall K-Series Attract Manual Wheelchair | Invacare Corporation | IOR | Class I | 2016-12-28 |
| K162696 | Kuschall Advance Manual Wheelchair | Invacare Corporation | IOR | Class I | 2016-12-28 |
| K162022 | Collagentex Rx-1 | Tanses Technologies, Inc. | NHN | Class II | 2016-12-22 |
| K161716 | TEETHAN 2.0 | Bts S.P.A. | KZM | Class II | 2016-12-21 |
| K160614 | Xcite Clinical Station | Restorative Therapies, Inc. | IPF | Class II | 2016-12-16 |
| K160849 | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 | Ws Far IR Medical Technology Co., Ltd. | ILY | Class II | 2016-12-15 |
| K161425 | APEX Manual Wheelchair | Motion Composites | IOR | Class I | 2016-12-05 |
| K152420 | AK Body Toning Device | Ak Beauty Enterprises, LLC | NGX | Class II | 2016-12-01 |
| K163067 | CyMedica e-vive System; CY-1000 | Cymedica Orthopedics, Inc. | IPF | Class II | 2016-12-01 |
| K162994 | Capillus302, Capillus312, Capillus352 | Capillus, LLC | OAP | Class II | 2016-11-18 |
| K162240 | ProMedTek Model C1400 Shortwave Diathermy Device | Promedtek, Inc. | IMJ | Class II | 2016-11-17 |
| K161862 | ThermoPro | Zimmer Medizinsysteme GmbH | IMJ | Class II | 2016-11-14 |
| K161628 | JAS Pulse(TM) Ultrasonic Therapy | Bonutti Research, Inc. | IMI | Class II | 2016-11-10 |
| K161974 | SLENDERTONE® Connect Abs, Type 570 | Bio-Medical Research, Ltd. | NGX | Class II | 2016-11-01 |
| K160992 | HPM-6000 | BTL Industries, Inc. | IPF | Class II | 2016-10-21 |
| K161241 | e-fix E35/E36 | Alber GmbH | ITI | Class II | 2016-10-05 |
| K160909 | ATTO Mobility Scooter | Moving Life, Ltd. | INI | Class II | 2016-10-04 |
| K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | OAP | Class II | 2016-09-30 |
| K160728 | NutraStim Hair Laser Helmet | Nutra Luxe MD, LLC | OAP | Class II | 2016-09-16 |
| K153636 | Liberator Powered Wheelchair with Solar Companion | Solar Mobilityllc | ITI | Class II | 2016-09-09 |
| K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System | Accelerated Care Plus (Acp) | IMG | Class II | 2016-08-26 |
| K160943 | Bite Away | Riemser Pharma | IRT | Class II | 2016-08-26 |
| K160075 | Accent XL | Alma Lasers, Inc. | IMI | Class II | 2016-08-17 |
| K161502 | MC1 Plus | General Project S.R.L. | IMI | Class II | 2016-08-16 |
| K152087 | HeatLux Pro II | Home Skinovations , Ltd. | ILY | Class II | 2016-07-29 |
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | ILY | Class II | 2016-07-26 |
| K160987 | ReWalk(TM) | Rewalk Robotics, Inc. | PHL | Class II | 2016-07-22 |
| K153328 | SUNCO Mechanical Wheelchair, model SKW-9003 | Danyang Sunco Machinery Co., Ltd. | IOR | Class I | 2016-07-20 |
| K161443 | Ekso (version 1.1) and Ekso GT (version 1.2) | Ekso Bionics, Inc. | PHL | Class II | 2016-07-19 |
| K160031 | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) | Sunrise Medical (Us), LLC | ITI | Class II | 2016-07-14 |
| K152461 | The Time Machine Series Lasers | Medical Lasers Manufacturer, Inc. | ILY | Class II | 2016-07-08 |
| K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System | Usa Laser Biotech, Inc. | ILY | Class II | 2016-07-05 |
| K153399 | LightStim Professional LED Bed | Led Intellectual Properties, LLC | ILY | Class II | 2016-07-05 |
| K153456 | Megapulse III Shortwave Diathermy | Accelerated Care Plus | IMJ | Class II | 2016-06-14 |
| K153713 | Getinge Series Warming Cabinet | Getinge Sourcing, LLC | LHC | Class I | 2016-06-07 |
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes | Bio Protech, Inc. | IKT | Class II | 2016-06-03 |
| K151492 | Kudu | R82 A/S | IOR | Class I | 2016-05-20 |
| K161046 | Laser Helmet LH40-EVO | Theradome, Inc. | OAP | Class II | 2016-05-12 |
| K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | OAP | Class II | 2016-04-25 |
| K151922 | StimSox(TM) System | Stimmed, LLC | IPF | Class II | 2016-04-15 |
| K153696 | Chattanooga Revolution Wireless | Djo, LLC | IPF | Class II | 2016-04-14 |
| K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | IRP | Class II | 2016-04-13 |
| K152056 | Winco Model S550 Stretchair | Winco Manufacturing, LLC | INK | Class II | 2016-04-11 |
| K160299 | geko(TM) Plus R-2 Neuromuscular Stimulator | Firstkind Limited | IPF | Class II | 2016-04-08 |
| K143690 | Ekso (version 1.1) and Ekso GT (version 1.2) | Ekso Bionics, Inc. | PHL | Class II | 2016-04-01 |
| K152021 | Pure Tilt | Proactive Comfort, LLC | IOR | Class I | 2016-03-31 |
| K152480 | Revitive Medic; Revitive MV; Revitive LV | Actegy , Ltd. | NGX | Class II | 2016-03-31 |
| K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | In Light Wellness Systems, Inc. | ILY | Class II | 2016-03-30 |
| K151722 | Slim UP ULTRA | Aime Medical, Inc. | NGX | Class II | 2016-03-18 |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | MPO | Class I | 2016-03-18 |
| K152280 | BioPhotas Celluma3 | Biophotas, Inc. | ILY | Class II | 2016-03-02 |
| K152416 | Indego | Parker Hannifin Corporation | PHL | Class II | 2016-02-26 |
| K151476 | Beactive Brace | Natures Pillows, Inc. | PMV | Class I | 2016-02-26 |
| K151717 | twion | Alber GmbH | ITI | Class II | 2016-02-23 |
| K152827 | Weely Manual Wheelchair | Rupiani | IOR | Class I | 2016-02-19 |
| K152196 | Erchonia EVRL | Erchonia Corporation | NHN | Class II | 2016-02-18 |
| K153224 | VitalStim(R) Plus Electrotherapy System | Djo, LLC | IPF | Class II | 2016-02-17 |
| K153543 | WHILL Model M | Whill, Inc. | ITI | Class II | 2016-02-12 |
| K153054 | N5-1 | Nuga Medical Co., Ltd. | JFB | Class II | 2016-02-05 |
| K151955 | YuGo System | Biogaming , Ltd. | LXJ | Class II | 2016-02-05 |
| K152587 | DermaScalp Laser Cap | Dermascalp, LLC | OAP | Class II | 2016-02-04 |
| K152878 | SUNTEC Mechanical Wheelchair, model ST-WL-1000 | Danyang Suntec Auto Parts Co., Ltd. | IOR | Class I | 2016-02-03 |
| K152672 | Cajun Commando 4x4 | Lil Critter, LLC | ITI | Class II | 2016-01-21 |
| K153618 | Capillus202 | Capillus, LLC | OAP | Class II | 2016-01-19 |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | Ecolab, Inc. | LHC | Class I | 2016-01-15 |
| K151662 | iRestore | Freedom Laser Therapy, Inc. | OAP | Class II | 2016-01-06 |
| K152536 | MyOn HC Manual Wheelchair | Invacare Corporation | IOR | Class I | 2016-01-05 |
| K153052 | Erchonia PL Touch | Erchonia Corporation | NHN | Class II | 2016-01-04 |
| K150716 | Varaya Sport | Varaya Photoceuticals, LLC | ILY | Class II | 2015-12-08 |
| K151656 | HEARTWAY Power Mobility Scooter | Heartway Medical Products Co., Ltd. | INI | Class II | 2015-11-25 |
| K151816 | TLC-2000 Therapeutic Medical Laser System | Theralase, Inc. | NHN | Class II | 2015-11-19 |
| K152019 | HairMD | Trophy Skin, Inc. | OAP | Class II | 2015-11-16 |
| K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | IMG | Class II | 2015-11-13 |
| K150353 | BTL-4000 | BTL Industries, Inc. | IMG | Class II | 2015-11-13 |
| K151903 | Slendertone connect Abs | Bio-Medical Research, Ltd. | NGX | Class II | 2015-11-06 |
| K150462 | Vera | Reflexion Health, Inc. | LXJ | Class II | 2015-10-30 |
| K152677 | geko T-2 Neuromuscular Stimulator | Firstkind Limited | IPF | Class II | 2015-10-23 |
| K151893 | P.R.O. CG Manual Wheelchair | Freedom Designs, Inc. | IOR | Class I | 2015-10-22 |
| K151640 | ELTRAC 471 | Enraf-Nonius, B.V. | ITH | Class II | 2015-10-16 |
| K150557 | Podimetrics Remote Temperature Monitoring System | Podimetrics,Inc. | OIZ | Class I | 2015-10-08 |
| K150554 | NuBrilliance Light Pain Therapy | Wellquest International, Inc. | ILY | Class II | 2015-10-06 |
| K150078 | PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application) | Smartmissimo Technologies Pte, Ltd. | NGX | Class II | 2015-09-30 |
| K150998 | HEARTWAY Power Mobility Scooter | Heartway Medical Products Co., Ltd. | INI | Class II | 2015-09-29 |
| K150987 | HEARTWAY Power Mobility Scooter, BRIO S19 | Heartway Medical Products Co., Ltd. | INI | Class II | 2015-09-22 |
| K151446 | Recovr Rehabilitation System | Recovr,Inc | LXJ | Class II | 2015-09-18 |
| K143557 | SupaScoota Motorized vehicle | Eurogreen International, Inc. | INI | Class II | 2015-09-16 |
| K151944 | Luggie Super | Freerider Corporation | INI | Class II | 2015-09-10 |
| K151521 | Phoenix Thera-Lase System | Phoenix Thera-Lase Systems, LLC | ILY | Class II | 2015-09-04 |
| K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm | Natus Manufacturing Limited | IKT | Class II | 2015-08-28 |
| K143512 | ActiSpec Activity Monitor | Sleep Modus, Inc. | ISD | Class II | 2015-08-26 |
| K142976 | UltraTENS | Shenzhen Dongdixin Technology Co., Ltd. | IMI | Class II | 2015-08-26 |
| K151797 | Nuocande Plastic Manual Wheelchair Model NKD L07 | Ningbo Lecount Medical Technology Co., Ltd. | IOR | Class I | 2015-08-25 |
| K151333 | LightStim for Pain LED Belt | Led Intellectual Properties, LLC | ILY | Class II | 2015-08-21 |
| K151516 | Capillus82 | Capillus, LLC | OAP | Class II | 2015-08-21 |
| K143458 | Neurosplint | Neurospectrum, LLC | IQI | Class I | 2015-08-13 |
| K150695 | Modpod | Hollywog, LLC | ITH | Class II | 2015-08-13 |
| K150086 | Titan | Tzora Active Systems , Ltd. | INI | Class II | 2015-08-05 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.