Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 23
- Latest Decision
- 2018-10-23
Clearances · page 8 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K182106 | BTL 799-2T | BTL Industries, Inc. | NGX | Class II | 2018-10-23 |
| K181728 | Muscle Trainer | Shenzhen Kentro Medical Electronics Co., Ltd. | NGX | Class II | 2018-10-17 |
| K181795 | AST Model MA012 and MS019 Rehab Wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | IOR | Class I | 2018-09-25 |
| K181199 | Katalyst Mark 1 Muscle Stimulation System Model 2 | Katalyst, Inc. | NGX | Class II | 2018-09-20 |
| K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co. , Ltd. | IPF | Class II | 2018-09-07 |
| K181878 | Kiierr 272 Laser, Kiierr 148 Laser | Kiierr International, LLC | OAP | Class II | 2018-09-05 |
| K181308 | SuperGrow 272, Ultimate 272 | Super Grow Lasers | OAP | Class II | 2018-08-15 |
| K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | OAP | Class II | 2018-08-10 |
| K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | IRP | Class II | 2018-08-03 |
| K171547 | Qualisys Clinical System | Qualisys AB | LXJ | Class II | 2018-08-02 |
| K180627 | Macroduct Advanced Model 3710 | Elitechgroup, Inc. | KTB | Class II | 2018-07-27 |
| K172440 | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 | Dongguan Prestige Sporting Goods., Ltd. | INI | Class II | 2018-07-13 |
| K173815 | Allergan Botox Needle Electrode | Natus Manufacturing Limited | IKT | Class II | 2018-06-29 |
| K180885 | HairMax Laser | Lexington International, LLC | OAP | Class II | 2018-06-20 |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE | Hightech Development | EGJ | Class II | 2018-06-15 |
| K180813 | BTL 799-2 | BTL Industries, Inc. | NGX | Class II | 2018-06-14 |
| K180617 | Hair Up | Y & J Bio Co., Ltd. | OAP | Class II | 2018-06-01 |
| K181059 | geko T-3 Neuromuscular Stimulator | Firstkind Limited | IPF | Class II | 2018-05-23 |
| K180197 | Erchonia FX-635 | Erchonia Corporation | NHN | Class II | 2018-05-21 |
| K180460 | Theradome LH40 | Theradome, Inc. | OAP | Class II | 2018-05-18 |
| K173931 | MindMotion(TM) GO | Mindmaze SA | LXJ | Class II | 2018-05-17 |
| K173360 | Athena 190 | Medical Rehab Products, LLC | IOR | Class I | 2018-05-17 |
| K180585 | Collagentex Rx-6 | Tanses Technologies, Inc. | NHN | Class II | 2018-05-11 |
| K172882 | UINCARE HOME | Uincare Corp. | LXJ | Class II | 2018-05-10 |
| K180279 | Silk'n MODEL H5003 device | Home Skinovations , Ltd. | NGX | Class II | 2018-05-09 |
| K172409 | Lite | Tzora Active Systems , Ltd. | INI | Class II | 2018-05-02 |
| K173300 | ViaTherm BOOST | Viatherm Therapeutics, LLC | IMJ | Class II | 2018-05-01 |
| K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | ISA | Class I | 2018-04-13 |
| K173846 | DermaScalp Laser Cap | Dermascalp, LLC | OAP | Class II | 2018-03-21 |
| K172381 | Digitimer DS7AP Constant Current Stimulator | Digitimer , Ltd. | IPF | Class II | 2018-03-06 |
| K172601 | Next Generation iBOT | Deka Research & Development Corp. | IMK | Class II | 2018-03-02 |
| K173729 | REVIAN RED | Photonmd, Inc. | OAP | Class II | 2018-02-28 |
| K173678 | Diode Laser Cap | Cosmo Far East Technology Limited | OAP | Class II | 2018-02-28 |
| K173315 | SupaChair Powered Wheelchair | Eurogreen International, Inc. | ITI | Class II | 2018-02-13 |
| K173313 | SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP | Eurogreen International, Inc. | ITI | Class II | 2018-02-13 |
| K180082 | geko T-2 and geko Plus R-2 | Firstkind, Ltd. | IPF | Class II | 2018-02-11 |
| K173530 | Indego(R) | Parker-Hannifin Corporation | PHL | Class II | 2018-01-31 |
| K171835 | Irradiation Aesthetic Device | Chongqing Peninsula Medical Technology Co., Ltd. | OAP | Class II | 2018-01-30 |
| K173843 | illumiflow 148 Laser Cap | Eglobal, LLC | OAP | Class II | 2018-01-26 |
| K172384 | Quickie(r) Q700-UP M | Sunrise Medical (Us), LLC | IPL | Class II | 2018-01-16 |
| K171354 | MR4 Laser | Multi Radiance Medical | NHN | Class II | 2018-01-13 |
| K163451 | Action Trackstander models TR1816, TR1820, TR2016, and TR2020 | Action Manufacturing, Inc. | IPL | Class II | 2018-01-12 |
| K171775 | Theradome LH80 PRO | Theradome, Inc. | OAP | Class II | 2018-01-09 |
| K172968 | Hair Up | Y & J Bio Co., Ltd. | OAP | Class II | 2018-01-05 |
| K172982 | SuperGrow 272, Ultimate 272 | Super Grow Lasers | OAP | Class II | 2017-12-19 |
| K172743 | Natus VikingQuest | Natus Neurology Incorporated | IKN | Class II | 2017-12-19 |
| K171909 | HAL for Medical Use (Lower Limb Type) | Cyberdyne, Inc. | PHL | Class II | 2017-12-17 |
| K172876 | PowerDot PD-01M | Smartmissimo Technologies Pte, Ltd. | NGX | Class II | 2017-12-04 |
| K170634 | Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 | Advanced Vehicle Concepts , Ltd. | INI | Class II | 2017-11-29 |
| K172241 | Tyece OTC EMS System, Model EM35 | Tyece , Ltd. | NGX | Class II | 2017-11-20 |
| K170517 | Merits Model R106/R136 Rehab Wheelchair | Merits Healthcare Industries (Suzhou) Co., Ltd. | IOR | Class I | 2017-11-16 |
| K171017 | Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T | Convaid Products, LLC | IOR | Class I | 2017-10-18 |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | Shenzhen Dongdixin Technology Co., Ltd. | IPF | Class II | 2017-10-02 |
| K171685 | Med4 Elite | Cool Systems, Inc. (Dba Game Ready) | IRP | Class II | 2017-09-29 |
| K171334 | Indego | Parker Hannifin Corporation | PHL | Class II | 2017-09-08 |
| K171035 | Katalyst Mark 1 Muscle Stimulation System | Katalyst, Inc. | NGX | Class II | 2017-09-06 |
| K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) | Brh Medical , Ltd. | IMI | Class II | 2017-08-25 |
| K171895 | Grivamax Hair Growth System | Leana Orders, Inc. | OAP | Class II | 2017-08-22 |
| K170787 | Powered Wheelchair DYW30A(D09) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | ITI | Class II | 2017-08-09 |
| K171071 | StimSox(TM) System | Stimmed, LLC | IPF | Class II | 2017-08-09 |
| K162744 | Everyway OTC EMS, Model EV-805 | Everyway Medical Instrument Co., Ltd. | NGX | Class II | 2017-08-03 |
| K163352 | Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | IOR | Class I | 2017-07-28 |
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | IMD | Class I | 2017-07-24 |
| K163150 | ViMove2 | Dorsavi, Ltd. | IKN | Class II | 2017-07-14 |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx | Invacare Corporation | ITI | Class II | 2017-07-12 |
| K171092 | XiniWave II Model ECS322P | International Trade Group, Inc. | NGX | Class II | 2017-07-10 |
| K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | ILY | Class II | 2017-07-07 |
| K163432 | Stellar LEAP | Pdg Product Design Group, Inc. | IOR | Class I | 2017-06-27 |
| K170918 | Compex Sport Elite | Djo, LLC | NGX | Class II | 2017-06-20 |
| K170903 | Compex Wireless USA | Djo, LLC | NGX | Class II | 2017-06-19 |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | Healthlight, LLC | ILY | Class II | 2017-06-13 |
| K171256 | Quingo Flyte Mobility Scooter | Agile Distributors, LLC | INI | Class II | 2017-06-08 |
| K171387 | EMS100 Tri-Wave Combination Stimulator | Elite Medical Supply of New York, LLC | IPF | Class II | 2017-05-31 |
| K162328 | Winner Transfer Wheelchair | Winner SG Pte, Ltd. | IOR | Class I | 2017-05-11 |
| K163204 | A08 Power wheelchair | Kunshan Aoshida Electric Technology Co., Ltd. | ITI | Class II | 2017-05-05 |
| K170068 | Softcure 96 | Wellray Medical Laser, Inc. | ILY | Class II | 2017-05-05 |
| K162952 | C.T.M. Mobility Scooter | Chien TI Enterprise Co., Ltd. | INI | Class II | 2017-05-03 |
| K170291 | IontoDC | Soterix Medical, Inc. | EGJ | Class II | 2017-05-01 |
| K162748 | MindMotionPRO | Mindmaze SA | LXJ | Class II | 2017-04-24 |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair | Invacare Corporation | IOR | Class I | 2017-04-17 |
| K163125 | geko T-2 and geko Plus R-2 Neuromuscular Stimulators | Firstkind Limited | IPF | Class II | 2017-04-10 |
| K160323 | FlowKeepers | Dk Electronics, LLC | NGX | Class II | 2017-04-06 |
| K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | OAP | Class II | 2017-04-04 |
| K170701 | GEN_2 and GEN_3 Mechanical Wheelchairs | Free Wheelchair Mission | IOR | Class I | 2017-03-24 |
| K160139 | Luggie Chair | Freerider Corporation | ITI | Class II | 2017-03-20 |
| K163201 | KYMCO EQ10D Scooter | Kwang Yang Motor Co., Ltd. | INI | Class II | 2017-03-16 |
| K161430 | Myoject Luer Lock Needle Electrode | Natus Manufacturing Limited | IKT | Class II | 2017-03-02 |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | IKN | Class II | 2017-03-01 |
| K163245 | Virtual Occupational Therapy Application (VOTA) | Barron Associates, Inc. | LXJ | Class II | 2017-02-28 |
| K162071 | IllumiFlow Laser Cap | Eglobal, LLC | OAP | Class II | 2017-02-24 |
| K161907 | Pressure Therapy System | Xiamen Senyang Co., Ltd. | IRP | Class II | 2017-02-23 |
| K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | NGX | Class II | 2017-02-22 |
| K163165 | AM-100 | BTL Industries, Inc. | NGX | Class II | 2017-02-16 |
| K162987 | FA100 SCCD (Sequential Continuous Contraction Device) | Flowaid Medical Technologies, Corp | IPF | Class II | 2017-02-14 |
| K162590 | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | ILY | Class II | 2017-02-14 |
| K152432 | ActiPatch(R) | Bioelectronics Corporation | PQY | Class II | 2017-02-03 |
| K160835 | Titan 3W | Tzora Active Systems , Ltd. | INI | Class II | 2017-02-02 |
| K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 | Capillus, LLC | OAP | Class II | 2017-01-31 |
| K163280 | RP Lite 760R | Mego Afek AC , Ltd. | IRP | Class II | 2017-01-27 |
| K162817 | Noddle(TM) | Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. | ILQ | Class II | 2017-01-18 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.