FDA Product Code
FDA Product Code IPF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5850
510(k) Clearances — 548 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-06-08 | Traditional | PDF ↗ |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | 2026-06-02 | Traditional | PDF ↗ |
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | 2026-05-27 | Special | PDF ↗ |
| K251083 | Compact II | Enraf-Nonius, B.V. | 2025-09-12 | Traditional | PDF ↗ |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025-06-04 | Traditional | PDF ↗ |
| K241488 | TrainFES Advance | Trainfes | 2025-02-05 | Traditional | PDF ↗ |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | 2024-12-19 | Abbreviated | PDF ↗ |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-10 | Traditional | PDF ↗ |
| K240234 | BTL-899MS | BTL Industries, Inc. | 2024-08-17 | Traditional | PDF ↗ |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | 2024-08-02 | Traditional | PDF ↗ |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | 2024-05-16 | Traditional | PDF ↗ |
| K233926 | accufit | Mettler Electronics Corporation | 2024-03-21 | Traditional | PDF ↗ |
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 | Abbreviated | PDF ↗ |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 | Traditional | PDF ↗ |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 | Traditional | PDF ↗ |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 | Traditional | PDF ↗ |
| K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | 2023-10-10 | Traditional | PDF ↗ |
| K223802 | accufit | Mettler Electronics Corporation | 2023-10-06 | Traditional | PDF ↗ |
| K221274 | StarFormer, TightWave | Fotona D.O.O. | 2023-09-29 | Traditional | PDF ↗ |
| K230167 | BACK 4 | Swims America Corp | 2023-09-14 | Traditional | PDF ↗ |
| K232334 | DEKA SIMON | El.En S.P.A. | 2023-09-01 | Special | PDF ↗ |
| K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Hilltek, LLC | 2023-01-17 | Traditional | PDF ↗ |
| K222201 | Biological Feedback and Stimulation System | Medlander Medical Technology, Inc. | 2022-10-21 | Traditional | PDF ↗ |
| K221958 | Flex-MI | Emsi, Inc. | 2022-10-21 | Traditional | PDF ↗ |
| K220994 | Shoulder PacemakerTM | Ncs Lab Srl | 2022-10-14 | Traditional | PDF ↗ |
| K213197 | MyOnyx System | Thought Technology , Ltd. | 2022-06-17 | Traditional | PDF ↗ |
| K220738 | Motive Knee Wrap | Cymedica Orthopedics, Inc. | 2022-05-12 | Traditional | PDF ↗ |
| K220327 | geko W-3 | Firstkind Limited | 2022-03-04 | Special | PDF ↗ |
| K213043 | Levator Elite (Model LE9011) | Shenzhen Dongdixin Technology Co., Ltd. | 2022-02-25 | Traditional | PDF ↗ |
| K212832 | TimeWaver Frequency | Timewaver Production GmbH | 2021-12-14 | Traditional | PDF ↗ |
| K212762 | geko W-2 | Firstkind Limited | 2021-11-29 | Traditional | PDF ↗ |
| K192746 | MyoWorx TM20 | Myoworx, Inc. | 2021-10-19 | Traditional | PDF ↗ |
| K210002 | STELLA BIO | Egzotech Sp. Z O. O. | 2021-10-01 | Traditional | PDF ↗ |
| K210674 | Shoulder Pacemaker | Ncs Lab Srl | 2021-08-24 | Traditional | PDF ↗ |
| K210938 | PowerDot PD-01MT2 Muscle Stimulator | Smartmissimo Technologies Pte, Ltd. | 2021-07-30 | Special | PDF ↗ |
| K211094 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2021-07-08 | Traditional | PDF ↗ |
| K210604 | Intellihab System | Cymedica Orthopedics, Inc. | 2021-06-03 | Traditional | PDF ↗ |
| K210979 | Prelivia | Rehabtronics, Inc. | 2021-05-13 | Traditional | PDF ↗ |
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | Ibramed Equipamentos Medicos | 2021-05-11 | Traditional | PDF ↗ |
| K202031 | Talent-Pro Electromagnetic Stimulator | Remed Co., Ltd. | 2021-05-06 | Traditional | PDF ↗ |
| K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021-05-03 | Traditional | PDF ↗ |
| K201285 | InMode Evolve System with the Tone Applicator | InMode , Ltd. | 2021-03-05 | Traditional | PDF ↗ |
| K210269 | PowerDot PD-01MT2 Muscle Stimulator | Smartmissimo Technologies Pte, Ltd. | 2021-02-23 | Special | PDF ↗ |
| K203488 | emField | Zimmer Medizinsysteme GmbH | 2021-02-19 | Traditional | PDF ↗ |
| K202648 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | 2020-12-08 | Traditional | PDF ↗ |
| K202079 | Physiq | El.En Electronic Engineering Spa | 2020-11-25 | Traditional | PDF ↗ |
| K202490 | Avid CT2 | Vision Quest Industries Inc./Dba VQ Orthocare | 2020-11-16 | Traditional | PDF ↗ |
| K200088 | g.Estim FES | G.Tec Medical Engineering GmbH | 2020-10-29 | Traditional | PDF ↗ |
| K201290 | Medline DeNovo 4Pro Electrical Stimulation Device | Medline Industries, Inc. | 2020-09-21 | Traditional | PDF ↗ |
| K201958 | ETD Family of Electrotherapy Devices | Therasigma, LLC | 2020-08-04 | Traditional | PDF ↗ |
| K193275 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020-04-11 | Traditional | PDF ↗ |
| K193045 | geko W-2 | Firstkind Limited | 2020-01-18 | Special | PDF ↗ |
| K183074 | TENS and EMS Stimulator, TENS Stimulator | Astek Technology , Ltd. | 2020-01-11 | Traditional | PDF ↗ |
| K192733 | RelieforMe TENS/EMS Device Model UPK-GE01 | Umeheal , Ltd. | 2019-12-23 | Traditional | PDF ↗ |
| K192249 | InMode System with Tone Applicator | InMode , Ltd. | 2019-12-17 | Traditional | PDF ↗ |
| K191113 | geko T-2 and geko T-3 Neuromuscular Stimulators | Firstkind Limited | 2019-09-18 | Traditional | PDF ↗ |
| K182163 | Shear Stress Therapeutics SST 3000 | Shear Stress Therapeutics, LLC | 2019-07-09 | Traditional | PDF ↗ |
| K181759 | PowerDot PD-01MT | Smartmissimo Technologies Pte, Ltd. | 2018-11-09 | Abbreviated | PDF ↗ |
| K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co. , Ltd. | 2018-09-07 | Traditional | PDF ↗ |
| K181059 | geko T-3 Neuromuscular Stimulator | Firstkind Limited | 2018-05-23 | Special | PDF ↗ |
| K172381 | Digitimer DS7AP Constant Current Stimulator | Digitimer , Ltd. | 2018-03-06 | Traditional | PDF ↗ |
| K180082 | geko T-2 and geko Plus R-2 | Firstkind, Ltd. | 2018-02-11 | Traditional | PDF ↗ |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | Shenzhen Dongdixin Technology Co., Ltd. | 2017-10-02 | Traditional | PDF ↗ |
| K171071 | StimSox(TM) System | Stimmed, LLC | 2017-08-09 | Traditional | PDF ↗ |
| K171387 | EMS100 Tri-Wave Combination Stimulator | Elite Medical Supply of New York, LLC | 2017-05-31 | Special | PDF ↗ |
| K163125 | geko T-2 and geko Plus R-2 Neuromuscular Stimulators | Firstkind Limited | 2017-04-10 | Traditional | PDF ↗ |
| K162987 | FA100 SCCD (Sequential Continuous Contraction Device) | Flowaid Medical Technologies, Corp | 2017-02-14 | Traditional | PDF ↗ |
| K160614 | Xcite Clinical Station | Restorative Therapies, Inc. | 2016-12-16 | Traditional | PDF ↗ |
| K163067 | CyMedica e-vive System; CY-1000 | Cymedica Orthopedics, Inc. | 2016-12-01 | Traditional | PDF ↗ |
| K160992 | HPM-6000 | BTL Industries, Inc. | 2016-10-21 | Traditional | PDF ↗ |
| K151922 | StimSox(TM) System | Stimmed, LLC | 2016-04-15 | Traditional | PDF ↗ |
| K153696 | Chattanooga Revolution Wireless | Djo, LLC | 2016-04-14 | Traditional | PDF ↗ |
| K160299 | geko(TM) Plus R-2 Neuromuscular Stimulator | Firstkind Limited | 2016-04-08 | Special | PDF ↗ |
| K153224 | VitalStim(R) Plus Electrotherapy System | Djo, LLC | 2016-02-17 | Traditional | PDF ↗ |
| K152677 | geko T-2 Neuromuscular Stimulator | Firstkind Limited | 2015-10-23 | Special | PDF ↗ |
| K150742 | Muscle Stimulation System 110 | Niveus Medical, Inc. | 2015-07-23 | Special | PDF ↗ |
| K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator | Cymedica Orthopedics, Inc. | 2015-04-02 | Traditional | PDF ↗ |
| K140467 | FLEX-MT + | Emsi | 2014-10-07 | Traditional | PDF ↗ |
| K133638 | GEKO | Firstkind Limited | 2014-08-21 | Traditional | PDF ↗ |
| K131917 | NEURODYN COMPACT, NEURODYN II | Ibramed Equipamentos Medicos | 2014-04-29 | Traditional | PDF ↗ |
| K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM | Djo, LLC | 2014-04-10 | Traditional | PDF ↗ |
| K130052 | TONE-A-MATIC | Tone-A-Matic International, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K130691 | ELECTROTHERAPY DEVICE (COMBO UNIT) | Guangzhou Finecure Medical Equipment Co.,Ltd | 2013-12-20 | Traditional | PDF ↗ |
| K131629 | NEURODYN MULTIWAVE, AUSSIE SPORT | Ibramed Equipamentos Medicos | 2013-11-26 | Traditional | PDF ↗ |
| K131222 | AMPCARE ESP THERAPY SYSTEM | Ampcare, LLC | 2013-10-31 | Traditional | PDF ↗ |
| K132137 | MULTISTIM | Metron Medical Australia, Pty, Ltd. | 2013-09-12 | Special | PDF ↗ |
| K130424 | STIMEL-03 | Stimel, Ltd. | 2013-07-11 | Traditional | PDF ↗ |
| K123354 | REVITIVE IX | Actegy , Ltd. | 2013-06-28 | Traditional | PDF ↗ |
| K124016 | EMPI PHOENIX | Djo, LLC | 2013-05-06 | Abbreviated | PDF ↗ |
| K123642 | MUSCLE STIMULATION SYSTEM | Niveus Medical, Inc. | 2013-03-29 | Traditional | PDF ↗ |
| K120922 | GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT | Selectivemed Components, Inc. | 2013-02-07 | Abbreviated | PDF ↗ |
| K113010 | FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR | Famidoc Technology Co., Ltd. | 2012-12-21 | Traditional | PDF ↗ |
| K113017 | SYS*STIM 240 | Mettler Electronics Corp. | 2012-06-26 | Abbreviated | PDF ↗ |
| K112148 | POWERED MUSCLE STIMULATOR | Valmed, SA | 2012-04-30 | Traditional | PDF ↗ |
| K112348 | RS-4I MUSCLE STIMULATOR | Rs Medical | 2012-01-19 | Special | PDF ↗ |
| K111279 | NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM | Zynex Medical, Inc. | 2011-09-20 | Abbreviated | PDF ↗ |
| K103738 | H-WAVE | Electronic Waveform Laboratory, Inc. | 2011-06-01 | Special | PDF ↗ |
| K100862 | BODYFLOW P2CH | Physiomed Elektromedizin AG | 2011-04-21 | Traditional | PDF ↗ |
| K092202 | ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT | Eswallow USA | 2011-02-10 | Traditional | PDF ↗ |
| K102202 | GS 3000 | Emsi | 2010-11-23 | Traditional | PDF ↗ |
Product code IPF · Class II · Physical Medicine. Data: openFDA.