Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GZI — Predicate Candidate Screening
61 FDA 510(k) clearances under this product code; the 50 most recent screened below.
123 daysmedian FDA review time
308 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | 2025-06-05 | 269 | 0 |
| K243828 | CIONIC NEURAL SLEEVE (NS-200) | Cionic, Inc. | 2025-05-02 | 140 | 0 |
| K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | 2024-11-22 | 261 | 0 |
| K233006 | MyndMove, MyndMove 2.0 | Myndtec, Inc. | 2024-06-25 | 277 | 0 |
| K230997 | EvoWalk 1.0 System | Evolution Devices, Inc. | 2023-12-28 | 265 | 0 |
| K221823 | Cionic Neural Sleeve NS-100 | Cionic | 2022-07-21 | 28 | 0 |
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn, LLC | 2022-04-25 | 130 | 0 |
| K212149 | MyndMove 2.0 | Myndtec, Inc. | 2022-03-03 | 237 | 0 |
| K213622 | Cionic Neural Sleeve NS-100 | Cionic | 2022-02-14 | 90 | 0 |
| K202110 | MStim Drop Model: LGT-233 | Guangzhou Longest Science & Technology Co., Ltd. | 2021-11-05 | 463 | 0 |
| K193276 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020-09-23 | 302 | 0 |
| K200262 | L100 Go System | Bioness, Inc. | 2020-03-04 | 30 | 0 |
| K191587 | L360 Thigh System | Bioness, Inc. | 2019-09-12 | 90 | 0 |
| K190285 | L300 Go System | Bioness, Inc. | 2019-03-14 | 31 | 0 |
| K173682 | L300 Go System | Bioness, Inc. | 2018-03-09 | 98 | 0 |
| K171396 | ODFS Pace XL | Odstock Medical, Ltd. | 2018-01-31 | 265 | 0 |
| K162718 | Foot Drop System (Model XFT-2001D) | Shenzhen Xft Medical Limited | 2017-11-30 | 427 | 0 |
| K170564 | MyndMove System, MyndMove Functional Electrical Stimulator | Myndtec, Inc. | 2017-08-30 | 184 | 0 |
| K162470 | RT300 FES cycle ergometer | Restorative Therapies, Inc. | 2017-07-11 | 308 | 0 |
| K170132 | MyoCycle Home, MyoCycle Pro | Myolyn, LLC | 2017-04-25 | 98 | 0 |
| K162683 | RehaStim 2 | Hasomed GmbH | 2017-02-03 | 130 | 0 |
| K162407 | L300 Go System | Bioness, Inc. | 2017-01-27 | 151 | 0 |
| K153163 | ReGrasp | Rehabtronics, Inc. | 2016-04-07 | 157 | 0 |
| K141812 | MYGAIT STIMULATION SYSTEM | Otto Bock Healthcare Products GmbH | 2015-04-02 | 269 | 0 |
| K140886 | WALKAIDE SYSTEM | Innovative Neurotronics, Inc. | 2014-08-08 | 123 | 0 |
| K131923 | NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS | Techlink International | 2014-07-03 | 372 | 0 |
| K132416 | REHASTIM 2, ERIGOPRO (FES) | Hasomed GmbH | 2014-05-28 | 299 | 0 |
| K123636 | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTEL | Bioness, Inc. | 2013-05-01 | 159 | 0 |
| K123972 | WALKAIDE SYSTEM | Innovative Neurotronics, Inc. | 2013-04-01 | 96 | 0 |
| K122784 | NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM K | Bioness, Inc. | 2012-12-27 | 107 | 0 |
| K120853 | NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMA | Bioness, Inc. | 2012-04-20 | 30 | 0 |
| K112844 | REHASTIM 2, REHAMOVE 2 | Hasomed GmbH | 2011-10-27 | 28 | 0 |
| K111767 | NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND C | Ness-Neuromuscular Electrical Stimulation Systems | 2011-09-15 | 84 | 0 |
| K103343 | L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT | Bioness, Inc. | 2011-04-29 | 165 | 0 |
| K103370 | RT200 | Restorative Therapies, Inc. | 2011-04-05 | 139 | 0 |
| K103366 | RT600 | Restorative Therapies, Inc. | 2011-04-04 | 139 | 0 |
| K102115 | ODFS PACE | Odstock Medical, Ltd. | 2011-03-30 | 245 | 0 |
| K090750 | RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 | Restorative Therapies, Inc. | 2009-08-05 | 138 | 0 |
| K080219 | MODIFICATION TO:NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008-02-28 | 30 | 0 |
| K073237 | REHASTIM & REHAMOVE | Hasomed GmbH | 2007-12-27 | 41 | 0 |
| K072398 | RT300-S AND RT300-SP FES CYCLE ERGOMETER | Restorative Therapies, Inc. | 2007-11-21 | 86 | 0 |
| K071486 | RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100 | Restorative Therapies, Inc. | 2007-09-10 | 103 | 0 |
| K071113 | RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL | Restorative Therapies, Inc. | 2007-07-05 | 76 | 0 |
| K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006-07-07 | 206 | 0 |
| K060032 | RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 | Restorative Therapies, Inc. | 2006-03-10 | 64 | 0 |
| K052329 | WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 | Innovative Neurotronics, Inc. | 2005-09-21 | 27 | 1 |
| K050991 | THE ODFS DROPPED FOOT STIMULATOR | Department of Medical Physics and Biomedical Eng. | 2005-07-15 | 87 | 0 |
| K050036 | FES CYCLE ERGOMETER, MODEL RT300-S | Restorative Therapies, Inc. | 2005-06-27 | 171 | 0 |
| K031900 | HANDMASTER | Ness-Neuromuscular Electrical Stimulation Systems | 2003-08-08 | 50 | 0 |
| K012823 | MODIFICATION TO HANDMASTER | Ness-Neuromuscular Electrical Stimulation Systems | 2001-11-14 | 90 | 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