Physical Medicine
5,638 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| iHelmet Hair Growth System (K190467) | Slinph Technologies Co., Ltd. | 2019-12-26 |
| RelieforMe TENS/EMS Device Model UPK-GE01 (K192733) | Umeheal , Ltd. | 2019-12-23 |
| LiteWalk (K192607) | Viasonix , Ltd. | 2019-12-19 |
| InMode System with Tone Applicator (K192249) | InMode , Ltd. | 2019-12-17 |
| Laser Hair Growth Cap (K192627) | Shang FA Biotechnology Co. | 2019-12-13 |
| C.T.M. Mobility Scooter HS-268 (K192885) | Chien TI Enterprise Co., Ltd. | 2019-12-09 |
| Hair Growth System (K191754) | Kunshan Bella Optical Technology Co., Ltd. | 2019-11-22 |
| CoolTone (K192940) | Zimmer Medizinsysteme GmbH | 2019-11-15 |
| HIVOX Spopad EMS SP-911, SP-921 (K192264) | Hivox Biotek, Inc. | 2019-11-08 |
| Compression Therapy Device Model LGT-2200SP (K191862) | Guangzhou Longest Science & Technology Co., Ltd. | 2019-10-29 |
| Game Ready GRPro 2.1 System (K192114) | Cool Systems, Inc. (Dba Game Ready) | 2019-10-29 |
| F5 Corpus VS (K191874) | Permobil AB | 2019-10-25 |
| Saalio (K191436) | Saalmann Medical GmbH & Co. KG | 2019-10-18 |
| NXPRO Neuromuscular Electrical Stimulation Device (K191181) | Neux Technologies, Inc. | 2019-10-11 |
| VERA (K192474) | Reflexion Health, Inc. | 2019-10-10 |
| Hair Boom 69, Hair Boom Air, Ulike Hair UpUp (K192425) | Wontech Co., Ltd. | 2019-09-30 |
| SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) (K182631) | Eurogreen International, Inc. | 2019-09-19 |
| ProPerformance Recovery System (K192252) | Menlo Brands, LLC | 2019-09-19 |
| EMS Belt (Model MC0485) (K183103) | Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | 2019-09-18 |
| geko T-2 and geko T-3 Neuromuscular Stimulators (K191113) | Firstkind Limited | 2019-09-18 |
| Capillus 112, Capillus 244 (K192012) | Capillus | 2019-09-12 |
| UPnRIDE (K182257) | Upnride Robotics , Ltd. | 2019-09-12 |
| Modular Power Standing System (K191376) | Motion Concepts | 2019-08-13 |
| Erchonia EVRL (K191257) | Erchonia Corporation | 2019-08-08 |
| Hair Boom 69 (K191154) | Wontech | 2019-07-29 |
| Hair Growth System (K190685) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-07-26 |
| BionicGym Powered Muscle Stimulator (K182794) | Medical Currents, Ltd. | 2019-07-18 |
| Scooter (K182471) | Tianjin Kepler Vehicle Industry Co. , Ltd. | 2019-07-10 |
| Shear Stress Therapeutics SST 3000 (K182163) | Shear Stress Therapeutics, LLC | 2019-07-09 |
| Revitive Medic Plus, Revitive Advanced 2 (K190924) | Actegy , Ltd. | 2019-07-05 |
| BTL 799-2L (K190456) | BTL Industries, Inc. | 2019-07-05 |
| IKON 40 Manual Wheelchair (K190550) | Broda Seating (Broda Lp) | 2019-07-01 |
| RecoveryRx (K190251) | Bioelectronics Corporation | 2019-06-28 |
| Scooter, Model: R-100 (K182411) | Yongkang Dingchang Industry & Trade Co., Ltd. | 2019-06-24 |
| emFieldPro (K182963) | Zimmer Medizinsysteme GmbH | 2019-06-21 |
| Miha Bodytec II (K182519) | Miha Bodytec GmbH | 2019-06-07 |
| ReWalk Restore (K190337) | Re Walk Robotics , Ltd. | 2019-06-03 |
| Erchonia FX-635 (K190572) | Erchonia Corporation | 2019-06-01 |
| Air Relax (K173158) | Maxstar Industrial Co., Ltd. | 2019-05-30 |
| Manual Wheelchair SIVFH2A102 (K190534) | Jiangsu Horizon Medical Science & Technology Co., Ltd. | 2019-05-29 |
| Solax Powered Wheelchair (K182576) | Dongguan Prestige Sporting Goods Co., Ltd. | 2019-05-21 |
| iRestore Professional 282 (K183417) | Freedom Laser Therapy, Inc. | 2019-05-17 |
| Recovery Pump, 737R (RPX) (K190493) | Mego Afek AC , Ltd. | 2019-05-15 |
| FLIX-EMS (K181419) | Casgarum Investment, S.L. | 2019-05-14 |
| Therm-X (K190854) | Zenith Technical Innovations | 2019-05-10 |
| Rowheels Revolution 1.0 (K190699) | Rowheels, Inc. | 2019-05-09 |
| Manual Wheelchair W54 (K180309) | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019-05-03 |
| Element Pediatric Wheelchair (K182840) | Leggero, LLC | 2019-04-29 |
| Phoenix (K183152) | Us Bionics, Inc. (Dba Suitx) | 2019-04-17 |
| Vera (K182333) | Reflexion Health, Inc. | 2019-04-09 |
| Xbody Newave USA (K190038) | Xbody Hungary Kft. | 2019-04-05 |
| Ballancer Gold, 1212 (K190015) | Mego Afek AC , Ltd. | 2019-03-25 |
| REAL Immersive System (K183296) | Penumbra, Inc. | 2019-03-18 |
| Bariatric Power Positioning System (BPPS) (K182995) | Motion Concepts | 2019-03-08 |
| DARI Health (K180880) | Scientific Analytics, Inc. | 2019-03-07 |
| Polar Care Wave (K183702) | Breg, Inc. | 2019-03-01 |
| Manual Wheelchair (K180852) | Jiangyin Newrise Medical Equipment Co., Ltd. | 2019-03-01 |
| Body System (K182440) | A-1 Engineering | 2019-02-26 |
| Tyece OTC EMS System (K183454) | Tyece , Ltd. | 2019-02-26 |
| Pressure Therapy System PT1003 (K181409) | Xiamen Senyang Co., Ltd. | 2019-02-19 |
| Wu's Powered Wheelchair (K181163) | Wu'S Tech Co., Ltd. | 2019-02-16 |
| WiEMSpro (K181955) | Medical Cables S.L. | 2019-02-12 |
| BTL-703 (K182363) | BTL Industries, Inc. | 2019-01-24 |
| Laser Hair Therapy (K183329) | Omm Imports, Inc. D/B/A Zero Gravity | 2019-01-16 |
| Pulse 2.0, Pulse Pro 2.0 (K183169) | NormaTec Industries, LP | 2018-12-27 |
| OrthoGold 100 (K182682) | Tissue Regeneration Technologies | 2018-12-21 |
| C.T.M Mobility Scooter (K181344) | Chien TI Enterprise Co., Ltd. | 2018-12-14 |
| Rapid Reboot Compression Therapy System (K182668) | Rapid Reboot Recovery Products, LLC | 2018-12-14 |
| Honda Walking Assist Device (K181294) | Honda Motor Company, Ltd. | 2018-12-14 |
| Invacare TDX SP2-HD with Captain's Seat (K182946) | Invacare Corporation | 2018-12-11 |
| Action Trackchair (K181908) | Action Manufacturing, Inc. | 2018-12-03 |
| AposTherapy System (K182090) | Apos Medical Assets , Ltd. | 2018-11-16 |
| Hair Boom 69 (K182562) | Wontech | 2018-11-16 |
| Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs (K181090) | Invacare Corporation | 2018-11-14 |
| PowerDot PD-01MT (K181759) | Smartmissimo Technologies Pte, Ltd. | 2018-11-09 |
| Hair Laser Headband (K182501) | Pulsaderm, LLC | 2018-10-26 |
| SLENDERTONE CoreFit Abs 8, Type 734 (K180688) | Bio-Medical Research, Ltd. | 2018-10-25 |
| BTL 799-2T (K182106) | BTL Industries, Inc. | 2018-10-23 |
| Muscle Trainer (K181728) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2018-10-17 |
| AST Model MA012 and MS019 Rehab Wheelchair (K181795) | Sichuan Ast Medical Equipment Co., Ltd. | 2018-09-25 |
| Katalyst Mark 1 Muscle Stimulation System Model 2 (K181199) | Katalyst, Inc. | 2018-09-20 |
| R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator (K181688) | Shenzhen Roundwhale Technology Co. , Ltd. | 2018-09-07 |
| Kiierr 272 Laser, Kiierr 148 Laser (K181878) | Kiierr International, LLC | 2018-09-05 |
| SuperGrow 272, Ultimate 272 (K181308) | Super Grow Lasers | 2018-08-15 |
| Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup (K181253) | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2018-08-10 |
| Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (K181149) | Zenith Technical Innovations | 2018-08-03 |
| Qualisys Clinical System (K171547) | Qualisys AB | 2018-08-02 |
| Macroduct Advanced Model 3710 (K180627) | Elitechgroup, Inc. | 2018-07-27 |
| Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 (K172440) | Dongguan Prestige Sporting Goods., Ltd. | 2018-07-13 |
| Allergan Botox Needle Electrode (K173815) | Natus Manufacturing Limited | 2018-06-29 |
| HairMax Laser (K180885) | Lexington International, LLC | 2018-06-20 |
| Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE (K170835) | Hightech Development | 2018-06-15 |
| BTL 799-2 (K180813) | BTL Industries, Inc. | 2018-06-14 |
| Hair Up (K180617) | Y & J Bio Co., Ltd. | 2018-06-01 |
| geko T-3 Neuromuscular Stimulator (K181059) | Firstkind Limited | 2018-05-23 |
| Erchonia FX-635 (K180197) | Erchonia Corporation | 2018-05-21 |
| Theradome LH40 (K180460) | Theradome, Inc. | 2018-05-18 |
| Athena 190 (K173360) | Medical Rehab Products, LLC | 2018-05-17 |
| MindMotion(TM) GO (K173931) | Mindmaze SA | 2018-05-17 |
| Collagentex Rx-6 (K180585) | Tanses Technologies, Inc. | 2018-05-11 |
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