Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IPF — Predicate Candidate Screening
548 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
338 days90th percentile
548clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-06-08 | 206 | 0 |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | 2026-06-02 | 271 | 0 |
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | 2026-05-27 | 127 | 0 |
| K251083 | Compact II | Enraf-Nonius, B.V. | 2025-09-12 | 156 | 0 |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025-06-04 | 379 | 0 |
| K241488 | TrainFES Advance | Trainfes | 2025-02-05 | 257 | 0 |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | 2024-12-19 | 318 | 0 |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-10 | 182 | 0 |
| K240234 | BTL-899MS | BTL Industries, Inc. | 2024-08-17 | 201 | 0 |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | 2024-08-02 | 311 | 0 |
| K232786 | Stimulation System (PA series, PR series, S series and Q ser | Edan Instruments, Inc. | 2024-05-16 | 248 | 0 |
| K233926 | accufit | Mettler Electronics Corporation | 2024-03-21 | 99 | 0 |
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 | 91 | 0 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 | 97 | 0 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 | 255 | 0 |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 | 169 | 0 |
| K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | 2023-10-10 | 376 | 0 |
| K223802 | accufit | Mettler Electronics Corporation | 2023-10-06 | 291 | 0 |
| K221274 | StarFormer, TightWave | Fotona D.O.O. | 2023-09-29 | 515 | 0 |
| K230167 | BACK 4 | Swims America Corp | 2023-09-14 | 237 | 0 |
| K232334 | DEKA SIMON | El.En S.P.A. | 2023-09-01 | 28 | 0 |
| K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Hilltek, LLC | 2023-01-17 | 424 | 0 |
| K222201 | Biological Feedback and Stimulation System | Medlander Medical Technology, Inc. | 2022-10-21 | 88 | 0 |
| K221958 | Flex-MI | Emsi, Inc. | 2022-10-21 | 108 | 0 |
| K220994 | Shoulder PacemakerTM | Ncs Lab Srl | 2022-10-14 | 193 | 0 |
| K213197 | MyOnyx System | Thought Technology , Ltd. | 2022-06-17 | 261 | 0 |
| K220738 | Motive Knee Wrap | Cymedica Orthopedics, Inc. | 2022-05-12 | 59 | 0 |
| K220327 | geko W-3 | Firstkind Limited | 2022-03-04 | 28 | 0 |
| K213043 | Levator Elite (Model LE9011) | Shenzhen Dongdixin Technology Co., Ltd. | 2022-02-25 | 156 | 0 |
| K212832 | TimeWaver Frequency | Timewaver Production GmbH | 2021-12-14 | 98 | 0 |
| K212762 | geko W-2 | Firstkind Limited | 2021-11-29 | 90 | 0 |
| K192746 | MyoWorx TM20 | Myoworx, Inc. | 2021-10-19 | 750 | 0 |
| K210002 | STELLA BIO | Egzotech Sp. Z O. O. | 2021-10-01 | 270 | 0 |
| K210674 | Shoulder Pacemaker | Ncs Lab Srl | 2021-08-24 | 172 | 0 |
| K210938 | PowerDot PD-01MT2 Muscle Stimulator | Smartmissimo Technologies Pte, Ltd. | 2021-07-30 | 123 | 0 |
| K211094 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2021-07-08 | 87 | 0 |
| K210604 | Intellihab System | Cymedica Orthopedics, Inc. | 2021-06-03 | 94 | 0 |
| K210979 | Prelivia | Rehabtronics, Inc. | 2021-05-13 | 42 | 0 |
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | Ibramed Equipamentos Medicos | 2021-05-11 | 74 | 0 |
| K202031 | Talent-Pro Electromagnetic Stimulator | Remed Co., Ltd. | 2021-05-06 | 288 | 0 |
| K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021-05-03 | 133 | 0 |
| K201285 | InMode Evolve System with the Tone Applicator | InMode , Ltd. | 2021-03-05 | 296 | 0 |
| K210269 | PowerDot PD-01MT2 Muscle Stimulator | Smartmissimo Technologies Pte, Ltd. | 2021-02-23 | 22 | 0 |
| K203488 | emField | Zimmer Medizinsysteme GmbH | 2021-02-19 | 84 | 0 |
| K202648 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | 2020-12-08 | 88 | 0 |
| K202079 | Physiq | El.En Electronic Engineering Spa | 2020-11-25 | 121 | 0 |
| K202490 | Avid CT2 | Vision Quest Industries Inc./Dba VQ Orthocare | 2020-11-16 | 77 | 0 |
| K200088 | g.Estim FES | G.Tec Medical Engineering GmbH | 2020-10-29 | 288 | 0 |
| K201290 | Medline DeNovo 4Pro Electrical Stimulation Device | Medline Industries, Inc. | 2020-09-21 | 130 | 0 |
| K201958 | ETD Family of Electrotherapy Devices | Therasigma, LLC | 2020-08-04 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda