Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 16
- Latest Decision
- 2021-09-28
Clearances · page 6 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K201855 | Electrically Powered Wheelchair -Model HP358E | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | 2021-09-28 |
| K200423 | Electric Wheelchair (XW-LY001) | Yongkang Dingchang Industry & Trade Co., Ltd. | ITI | Class II | 2021-09-22 |
| K211283 | Compressible Limb and Circulation Therapy System, Model POWER-Q2300 | Wonjin Mulsan Co., Ltd. | IRP | Class II | 2021-09-14 |
| K212491 | Air Relax Pro Model AR-4.0 | Diode Art Engineering Doing Business AS Air Relax | IRP | Class II | 2021-09-02 |
| K202395 | SP-1000, SP-2000 | Daesung Maref Co., Ltd. | IRP | Class II | 2021-09-01 |
| K202148 | E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) | Fit-Pro , Ltd. | NGX | Class II | 2021-08-25 |
| K210674 | Shoulder Pacemaker | Ncs Lab Srl | IPF | Class II | 2021-08-24 |
| K211513 | sam X1 Long Duration Ultrasound Device | ZetrOZ Systems, LLC | PFW | Class II | 2021-08-18 |
| K210913 | V12 PRO | Slk Medical GmbH | IRP | Class II | 2021-08-04 |
| K210938 | PowerDot PD-01MT2 Muscle Stimulator | Smartmissimo Technologies Pte, Ltd. | IPF | Class II | 2021-07-30 |
| K211192 | Grivamax Family of Lasers, Models 272 and 148 | Leana Orders, Inc. | OAP | Class II | 2021-07-20 |
| K201473 | ExoAtlet-II | Exoatlet Asia Co. , Ltd. | PHL | Class II | 2021-07-16 |
| K202638 | Pain Therapy Device | Guangzhou Xinbo Electronic Co., Ltd. | NGX | Class II | 2021-07-15 |
| K192739 | Electric Wheelchair [Models: JRWD6010/JRWD6012] | Jerry Medical Instrument (Shanghai) Co., Ltd. | ITI | Class II | 2021-07-13 |
| K211574 | Extreme X8 | Magic Mobility | ITI | Class II | 2021-07-09 |
| K211094 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | IPF | Class II | 2021-07-08 |
| K203498 | LX9max | Daesung Maref Co., Ltd. | IRP | Class II | 2021-07-02 |
| K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | OAP | Class II | 2021-06-29 |
| K201196 | Scooter (Model: FDB01) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | INI | Class II | 2021-06-25 |
| K203019 | LF900 | Daesung Maref Co., Ltd. | IRP | Class II | 2021-06-22 |
| K201935 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | IRP | Class II | 2021-06-22 |
| K210281 | Fist Assist Devices Model FA-1 | Fist Assist Devices, LLC | IRP | Class II | 2021-06-17 |
| K210920 | iBOT Personal Mobility Device (iBOT PMD) | Mobius Mobility | IMK | Class II | 2021-06-16 |
| K200466 | Manual Wheelchair (Model W28) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | IOR | Class I | 2021-06-14 |
| K210604 | Intellihab System | Cymedica Orthopedics, Inc. | IPF | Class II | 2021-06-03 |
| K211460 | Air Relax Plus Model AR-3.0 | Diode Art Engineering Doing Business AS Air Relax | IRP | Class II | 2021-05-25 |
| K201461 | Manual Wheelchair, Model A011 | Ningbo Shenyu Medical Equipment Co.,Ltd | IOR | Class I | 2021-05-21 |
| K203806 | JWX-1 Plus (Navigo 16/Navigo 24) | Yamaha Motor Co., Ltd. | ITI | Class II | 2021-05-21 |
| K210979 | Prelivia | Rehabtronics, Inc. | IPF | Class II | 2021-05-13 |
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | Ibramed Equipamentos Medicos | IPF | Class II | 2021-05-11 |
| K210967 | Air Pressure Therapy System: VU-IPC06 | Xiamen Weiyou Intelligent Technology Co., Ltd. | IRP | Class II | 2021-05-11 |
| K190737 | Solax Electric Scooter (Models: S204311M, S204161, S204143) | Dongguan Prestige Sporting Goods Co., Ltd. | INI | Class II | 2021-05-10 |
| K202031 | Talent-Pro Electromagnetic Stimulator | Remed Co., Ltd. | IPF | Class II | 2021-05-06 |
| K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | ISA | Class I | 2021-05-05 |
| K203525 | D function | Ito Co., Ltd. | NUW | Class II | 2021-05-05 |
| K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | IPF | Class II | 2021-05-03 |
| K192190 | Solax Electric Scooter | Dongguan Prestige Sporting Goods Co., Ltd. | INI | Class II | 2021-04-23 |
| K202506 | Karma Powered Wheelchair | Karma Medical Products Co., Ltd. | ITI | Class II | 2021-04-19 |
| K200978 | Electric Wheelchair (Model: S7110) | Dongguan Prestige Sporting Goods Co., Ltd. | ITI | Class II | 2021-04-16 |
| K210169 | Hair Growth Device | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. | OAP | Class II | 2021-04-16 |
| K202632 | Electric wheelchair (S7204/S7205) | Dongguan Prestige Sporting Goods Co., Ltd. | ITI | Class II | 2021-04-08 |
| K201257 | MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) | Arrive Systems, Inc. | NGX | Class II | 2021-04-06 |
| K203826 | LaserCap Family of Lasers 300, 224, 120 & 80 | Transdermal Cap, Inc. | OAP | Class II | 2021-03-29 |
| K201982 | Air compression therapy system FO-3001; Air compression therapy system FO-3008 | Foshan Hongfeng Co., Ltd. | IRP | Class II | 2021-03-25 |
| K202379 | Invacare AVIVA Storm RX Power Chair | Invacare Corporation | ITI | Class II | 2021-03-19 |
| K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 | Ceragem Co., Ltd. | JFB | Class II | 2021-03-18 |
| K202482 | Y207 Electric Wheelchair | Jiangsu Intco Medical Products Co., Ltd. | ITI | Class II | 2021-03-18 |
| K203083 | Magic 360 Power Wheelchair | Magic Mobility | ITI | Class II | 2021-03-17 |
| K201975 | miha bodytec II | Miha Bodytec GmbH | NGX | Class II | 2021-03-11 |
| K200660 | Compressible Limb and Circulation Therapy System | Wonjin Mulsan Co., Ltd. | IRP | Class II | 2021-03-08 |
| K202693 | NeoWave Pain Relief and Recovery System, Model# T16-2020 | Eva Medtec, Inc. | IRP | Class II | 2021-03-05 |
| K191441 | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) | Maxstar Industrial Co., Ltd. | IRP | Class II | 2021-03-05 |
| K201285 | InMode Evolve System with the Tone Applicator | InMode , Ltd. | IPF | Class II | 2021-03-05 |
| K202113 | Ceragem Automatic Thermal Massager, Model CGM-MB-1901 | Ceragem Co., Ltd. | JFB | Class II | 2021-03-02 |
| K202549 | Solax Electric Scooter (Model: S202261B) | Dongguan Prestige Sporting Goods Co., Ltd. | INI | Class II | 2021-02-26 |
| K210269 | PowerDot PD-01MT2 Muscle Stimulator | Smartmissimo Technologies Pte, Ltd. | IPF | Class II | 2021-02-23 |
| K210240 | Air Compression Therapy Device, model HW6007 | Konliking Tech & Dev. Limited | IRP | Class II | 2021-02-22 |
| K203488 | emField | Zimmer Medizinsysteme GmbH | IPF | Class II | 2021-02-19 |
| K203513 | SLENDERTONE Evolve Abs, Type 735 | Bio-Medical Research, Ltd. | NGX | Class II | 2021-02-10 |
| K191897 | Solax Electric Scooter (Models: S3023, S3024, S3025, S3026) | Dongguan Prestige Sporting Goods Co., Ltd. | INI | Class II | 2021-02-10 |
| K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | NGX | Class II | 2021-02-04 |
| K202653 | Gymform Total ABS | Well Brain International , Ltd. | NGX | Class II | 2021-01-15 |
| K193079 | ICE COMPRESSION FIRST, DUO, & MOOVE Systems | Mks Paris | IRP | Class II | 2021-01-11 |
| K200382 | BTL-703-2 | Btl | NGX | Class II | 2021-01-06 |
| K201239 | NuEra Tight Family, EMS Model | Bios S.R.L. | NGX | Class II | 2020-12-31 |
| K203552 | Rapid Reboot | Rapid Reboot Recovery Products, LLC | IRP | Class II | 2020-12-22 |
| K192308 | Wu's Electrical Scooter | Wu'S Tech Co., Ltd. | INI | Class II | 2020-12-21 |
| K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra | Lode B.V. | ISD | Class II | 2020-12-21 |
| K200857 | Electric wheelchair (Model: S7012) | Dongguan Prestige Sporting Goods Co., Ltd. | ITI | Class II | 2020-12-17 |
| K202028 | dermalux Flex MD | Aesthetic Technology, Ltd. | ILY | Class II | 2020-12-16 |
| K202337 | Pulsed electromagnetic field wrap | Hi-Dow International, Inc. | ILX | Class II | 2020-12-15 |
| K201354 | TENS & PMS | Hong Qiangxing (Shenzhen) Electronics Limited | NGX | Class II | 2020-12-11 |
| K202648 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | IPF | Class II | 2020-12-08 |
| K202983 | easy Hairfull | Y & J Bio Co., Ltd. | OAP | Class II | 2020-12-08 |
| K202631 | iHelmet Laser Comb | Slinph Technologies Co., Ltd. | OAP | Class II | 2020-12-08 |
| K193008 | Tricoglam Home Use | Advihair S.R.L. | OAP | Class II | 2020-12-03 |
| K201653 | Compex Sport Elite 3.0 | Djo, LLC | NGX | Class II | 2020-11-27 |
| K202079 | Physiq | El.En Electronic Engineering Spa | IPF | Class II | 2020-11-25 |
| K201694 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | IRP | Class II | 2020-11-19 |
| K202490 | Avid CT2 | Vision Quest Industries Inc./Dba VQ Orthocare | IPF | Class II | 2020-11-16 |
| K192618 | e-Motion M25 | Alber GmbH | ITI | Class II | 2020-11-02 |
| K200088 | g.Estim FES | G.Tec Medical Engineering GmbH | IPF | Class II | 2020-10-29 |
| K202044 | Powerpress Recovery Unit | Hanuri Distribution, Inc. | IRP | Class II | 2020-10-21 |
| K201845 | Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) | Guangzhou Longest Science & Technology Co., Ltd. | NGX | Class II | 2020-10-08 |
| K201559 | HAL for Medical Use(Lower Limb type) | Cyberdyne, Inc. | PHL | Class II | 2020-10-02 |
| K201290 | Medline DeNovo 4Pro Electrical Stimulation Device | Medline Industries, Inc. | IPF | Class II | 2020-09-21 |
| K182020 | Portable Electro-Stimulation Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. | NGX | Class II | 2020-09-17 |
| K201645 | Massage Compression Boots | Jkh USA, LLC | IRP | Class II | 2020-09-15 |
| K200135 | RGK Daily Range Wheelchairs | Rgk Wheelchairs, Ltd. | IOR | Class I | 2020-09-10 |
| K201539 | Keeogo Dermoskeleton System | B-Temia, Inc. | PHL | Class II | 2020-09-09 |
| K193599 | BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair | 21st Century Scientific, Inc. | ITI | Class II | 2020-09-03 |
| K201854 | CAPOGEN Laser Cap | Nature, Inc.redible, Inc. | OAP | Class II | 2020-09-01 |
| K191938 | FitRelief TENS&EMS Wireless Device | Heat IN A Click, LLC | NGX | Class II | 2020-08-28 |
| K200351 | PlasmaFlight | Manamed, Inc. | IRP | Class II | 2020-08-05 |
| K201958 | ETD Family of Electrotherapy Devices | Therasigma, LLC | IPF | Class II | 2020-08-04 |
| K200464 | LG Pra. L Derma LD Scalp Care | Lg Electronics.Inc | OAP | Class II | 2020-07-23 |
| K192466 | Air Compression Therapy System | Shenzhen Lifotronic Technology Co., Ltd. | IRP | Class II | 2020-06-22 |
| K200574 | EksoNR | Ekso Bionics, Inc. | PHL | Class II | 2020-06-19 |
| K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | IRP | Class II | 2020-06-08 |
| K200929 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | OAP | Class II | 2020-06-03 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.