Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 19
- Latest Decision
- 2020-05-29
Clearances · page 7 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K191334 | Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 | Matia Robotics (Us), Inc. | IPL | Class II | 2020-05-29 |
| K201131 | firefly T-2 | Firstkind Limited | NGX | Class II | 2020-05-28 |
| K200032 | ReWalk P6.0 | Re Walk Robotics , Ltd. | PHL | Class II | 2020-05-26 |
| K192016 | SMOOV O10 | Alber GmbH | ITI | Class II | 2020-05-19 |
| K192887 | Revitive Medic Plus, Revitive Advanced 2 | Actegy , Ltd. | NGX | Class II | 2020-05-04 |
| K192358 | Pressure Therapy System PT1003 | Xiamen Senyang Co., Ltd. | IRP | Class II | 2020-04-23 |
| K192552 | Irradiation Cosmetic Device | Chongqing Peninsula Medical Technology Co., Ltd. | OAP | Class II | 2020-04-17 |
| K182400 | Solax Powered Wheelchair (Models: S7101, S7103) | Dongguan Prestige Sporting Goods Co., Ltd. | ITI | Class II | 2020-04-14 |
| K193275 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | IPF | Class II | 2020-04-11 |
| K192658 | Manual Wheelchair | Jerry Medical Instrument (Shanghai) Co., Ltd. | IOR | Class I | 2020-04-01 |
| K192039 | Torc Body | Johari Digital Healthcare Limited | NGX | Class II | 2020-03-29 |
| K193667 | Shapiro MD model laser 272 | Conversion Labs, Pr, LLC | OAP | Class II | 2020-03-25 |
| K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | PFW | Class II | 2020-03-06 |
| K193550 | Therm-X | Zenith Technical Innovations | IRP | Class II | 2020-02-28 |
| K190682 | Explorer Mini | Permobil AB | IPL | Class II | 2020-02-27 |
| K192749 | Dermadry | Dermadry Laboratories, Inc. | EGJ | Class II | 2020-02-10 |
| K190966 | Katalyst Training System | Katalyst, Inc. | NGX | Class II | 2020-02-03 |
| K192234 | ActiPatch | Bioelectronics Corporation | PQY | Class II | 2020-01-31 |
| K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | OAP | Class II | 2020-01-29 |
| K192161 | FastFit EMS System | Fast Fit, LLC | NGX | Class II | 2020-01-22 |
| K193045 | geko W-2 | Firstkind Limited | IPF | Class II | 2020-01-18 |
| K183074 | TENS and EMS Stimulator, TENS Stimulator | Astek Technology , Ltd. | IPF | Class II | 2020-01-11 |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP | Invacare Corporation | ITI | Class II | 2020-01-02 |
| K190467 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | OAP | Class II | 2019-12-26 |
| K192733 | RelieforMe TENS/EMS Device Model UPK-GE01 | Umeheal , Ltd. | IPF | Class II | 2019-12-23 |
| K192607 | LiteWalk | Viasonix , Ltd. | IRP | Class II | 2019-12-19 |
| K192249 | InMode System with Tone Applicator | InMode , Ltd. | IPF | Class II | 2019-12-17 |
| K192627 | Laser Hair Growth Cap | Shang FA Biotechnology Co. | OAP | Class II | 2019-12-13 |
| K192885 | C.T.M. Mobility Scooter HS-268 | Chien TI Enterprise Co., Ltd. | INI | Class II | 2019-12-09 |
| K191754 | Hair Growth System | Kunshan Bella Optical Technology Co., Ltd. | OAP | Class II | 2019-11-22 |
| K192940 | CoolTone | Zimmer Medizinsysteme GmbH | NGX | Class II | 2019-11-15 |
| K192264 | HIVOX Spopad EMS SP-911, SP-921 | Hivox Biotek, Inc. | NGX | Class II | 2019-11-08 |
| K192114 | Game Ready GRPro 2.1 System | Cool Systems, Inc. (Dba Game Ready) | IRP | Class II | 2019-10-29 |
| K191862 | Compression Therapy Device Model LGT-2200SP | Guangzhou Longest Science & Technology Co., Ltd. | IRP | Class II | 2019-10-29 |
| K191874 | F5 Corpus VS | Permobil AB | IPL | Class II | 2019-10-25 |
| K191436 | Saalio | Saalmann Medical GmbH & Co. KG | EGJ | Class II | 2019-10-18 |
| K191181 | NXPRO Neuromuscular Electrical Stimulation Device | Neux Technologies, Inc. | NGX | Class II | 2019-10-11 |
| K192474 | VERA | Reflexion Health, Inc. | LXJ | Class II | 2019-10-10 |
| K192425 | Hair Boom 69, Hair Boom Air, Ulike Hair UpUp | Wontech Co., Ltd. | OAP | Class II | 2019-09-30 |
| K182631 | SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) | Eurogreen International, Inc. | INI | Class II | 2019-09-19 |
| K192252 | ProPerformance Recovery System | Menlo Brands, LLC | IRP | Class II | 2019-09-19 |
| K191113 | geko T-2 and geko T-3 Neuromuscular Stimulators | Firstkind Limited | IPF | Class II | 2019-09-18 |
| K183103 | EMS Belt (Model MC0485) | Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | NGX | Class II | 2019-09-18 |
| K182257 | UPnRIDE | Upnride Robotics , Ltd. | IPL | Class II | 2019-09-12 |
| K192012 | Capillus 112, Capillus 244 | Capillus | OAP | Class II | 2019-09-12 |
| K191376 | Modular Power Standing System | Motion Concepts | IPL | Class II | 2019-08-13 |
| K191257 | Erchonia EVRL | Erchonia Corporation | NHN | Class II | 2019-08-08 |
| K191154 | Hair Boom 69 | Wontech | OAP | Class II | 2019-07-29 |
| K190685 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | OAP | Class II | 2019-07-26 |
| K182794 | BionicGym Powered Muscle Stimulator | Medical Currents, Ltd. | NGX | Class II | 2019-07-18 |
| K182471 | Scooter | Tianjin Kepler Vehicle Industry Co. , Ltd. | INI | Class II | 2019-07-10 |
| K182163 | Shear Stress Therapeutics SST 3000 | Shear Stress Therapeutics, LLC | IPF | Class II | 2019-07-09 |
| K190924 | Revitive Medic Plus, Revitive Advanced 2 | Actegy , Ltd. | NGX | Class II | 2019-07-05 |
| K190456 | BTL 799-2L | BTL Industries, Inc. | NGX | Class II | 2019-07-05 |
| K190550 | IKON 40 Manual Wheelchair | Broda Seating (Broda Lp) | IOR | Class I | 2019-07-01 |
| K190251 | RecoveryRx | Bioelectronics Corporation | ILX | Class II | 2019-06-28 |
| K182411 | Scooter, Model: R-100 | Yongkang Dingchang Industry & Trade Co., Ltd. | INI | Class II | 2019-06-24 |
| K182963 | emFieldPro | Zimmer Medizinsysteme GmbH | NGX | Class II | 2019-06-21 |
| K182519 | Miha Bodytec II | Miha Bodytec GmbH | NGX | Class II | 2019-06-07 |
| K190337 | ReWalk Restore | Re Walk Robotics , Ltd. | PHL | Class II | 2019-06-03 |
| K190572 | Erchonia FX-635 | Erchonia Corporation | NHN | Class II | 2019-06-01 |
| K173158 | Air Relax | Maxstar Industrial Co., Ltd. | IRP | Class II | 2019-05-30 |
| K190534 | Manual Wheelchair SIVFH2A102 | Jiangsu Horizon Medical Science & Technology Co., Ltd. | IOR | Class I | 2019-05-29 |
| K182576 | Solax Powered Wheelchair | Dongguan Prestige Sporting Goods Co., Ltd. | ITI | Class II | 2019-05-21 |
| K183417 | iRestore Professional 282 | Freedom Laser Therapy, Inc. | OAP | Class II | 2019-05-17 |
| K190493 | Recovery Pump, 737R (RPX) | Mego Afek AC , Ltd. | IRP | Class II | 2019-05-15 |
| K181419 | FLIX-EMS | Casgarum Investment, S.L. | NGX | Class II | 2019-05-14 |
| K190854 | Therm-X | Zenith Technical Innovations | IRP | Class II | 2019-05-10 |
| K190699 | Rowheels Revolution 1.0 | Rowheels, Inc. | IOR | Class I | 2019-05-09 |
| K180309 | Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. | IOR | Class I | 2019-05-03 |
| K182840 | Element Pediatric Wheelchair | Leggero, LLC | IOR | Class I | 2019-04-29 |
| K183152 | Phoenix | Us Bionics, Inc. (Dba Suitx) | PHL | Class II | 2019-04-17 |
| K182333 | Vera | Reflexion Health, Inc. | LXJ | Class II | 2019-04-09 |
| K190038 | Xbody Newave USA | Xbody Hungary Kft. | NGX | Class II | 2019-04-05 |
| K190015 | Ballancer Gold, 1212 | Mego Afek AC , Ltd. | IRP | Class II | 2019-03-25 |
| K183296 | REAL Immersive System | Penumbra, Inc. | ISD | Class II | 2019-03-18 |
| K182995 | Bariatric Power Positioning System (BPPS) | Motion Concepts | ITI | Class II | 2019-03-08 |
| K180880 | DARI Health | Scientific Analytics, Inc. | LXJ | Class II | 2019-03-07 |
| K183702 | Polar Care Wave | Breg, Inc. | IRP | Class II | 2019-03-01 |
| K180852 | Manual Wheelchair | Jiangyin Newrise Medical Equipment Co., Ltd. | IOR | Class I | 2019-03-01 |
| K183454 | Tyece OTC EMS System | Tyece , Ltd. | NGX | Class II | 2019-02-26 |
| K182440 | Body System | A-1 Engineering | NGX | Class II | 2019-02-26 |
| K181409 | Pressure Therapy System PT1003 | Xiamen Senyang Co., Ltd. | IRP | Class II | 2019-02-19 |
| K181163 | Wu's Powered Wheelchair | Wu'S Tech Co., Ltd. | ITI | Class II | 2019-02-16 |
| K181955 | WiEMSpro | Medical Cables S.L. | NGX | Class II | 2019-02-12 |
| K182363 | BTL-703 | BTL Industries, Inc. | IMJ | Class II | 2019-01-24 |
| K183329 | Laser Hair Therapy | Omm Imports, Inc. D/B/A Zero Gravity | OAP | Class II | 2019-01-16 |
| K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | IRP | Class II | 2018-12-27 |
| K182682 | OrthoGold 100 | Tissue Regeneration Technologies | ISA | Class I | 2018-12-21 |
| K181344 | C.T.M Mobility Scooter | Chien TI Enterprise Co., Ltd. | INI | Class II | 2018-12-14 |
| K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | IRP | Class II | 2018-12-14 |
| K181294 | Honda Walking Assist Device | Honda Motor Company, Ltd. | PHL | Class II | 2018-12-14 |
| K182946 | Invacare TDX SP2-HD with Captain's Seat | Invacare Corporation | ITI | Class II | 2018-12-11 |
| K181908 | Action Trackchair | Action Manufacturing, Inc. | ITI | Class II | 2018-12-03 |
| K182562 | Hair Boom 69 | Wontech | OAP | Class II | 2018-11-16 |
| K182090 | AposTherapy System | Apos Medical Assets , Ltd. | QDT | Class I | 2018-11-16 |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | Invacare Corporation | IOR | Class I | 2018-11-14 |
| K181759 | PowerDot PD-01MT | Smartmissimo Technologies Pte, Ltd. | IPF | Class II | 2018-11-09 |
| K182501 | Hair Laser Headband | Pulsaderm, LLC | OAP | Class II | 2018-10-26 |
| K180688 | SLENDERTONE CoreFit Abs 8, Type 734 | Bio-Medical Research, Ltd. | NGX | Class II | 2018-10-25 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.