Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GZJ — Predicate Candidate Screening
606 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
311 days90th percentile
606clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | 2026-05-28 | 274 | 0 |
| K252767 | actiTENS mini | Sublimed | 2026-01-16 | 140 | 0 |
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025-08-15 | 29 | 0 |
| K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024-08-30 | 382 | 0 |
| K241228 | TENSWave | Zynex Medical Officer | 2024-08-27 | 117 | 0 |
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | 2024-04-19 | 207 | 0 |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS | Wuxi Jiajian Medical Instrument Co., Ltd. | 2023-01-24 | 124 | 0 |
| K212618 | iRelieve Microcurrent Pain Relief System | Fast Track Technologies, Inc. | 2022-09-14 | 392 | 0 |
| K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | 2022-08-26 | 263 | 0 |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-05-25 | 86 | 0 |
| K220503 | TENS device-EmeTerm 2, Model: YF-ZTY-E2 | Wat Medical Technology, Inc. | 2022-04-23 | 60 | 0 |
| K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-06-18 | 263 | 0 |
| K202186 | TrueRelief Device | Truerelief | 2021-03-23 | 231 | 0 |
| K210202 | BioWaveGO RX | Biowave Corporation | 2021-02-24 | 30 | 0 |
| K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | 2020-12-23 | 205 | 0 |
| K202159 | actiTENS | Sublimed | 2020-12-22 | 141 | 0 |
| K201431 | OGYILI TENS/NMES Stimulator | Gongguan Tutamen Metalwork Co., Ltd. | 2020-11-09 | 161 | 0 |
| K181645 | StimaWELL 120MTRS | Pierenkemper GmbH | 2020-08-13 | 783 | 0 |
| K191547 | ReliefBand | Reliefband Technologies, LLC | 2019-08-30 | 79 | 0 |
| K182960 | ReliefBand | Reliefband Technologies, LLC | 2019-06-21 | 239 | 0 |
| K182025 | ClearUP Sinus Pain Relief | Tivic Health Systems, Inc. | 2019-01-02 | 156 | 0 |
| K180943 | BioWaveGO | Biowave Corporation | 2018-08-17 | 129 | 0 |
| K172478 | TENS device-EmeTerm, CinvStop | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-04-19 | 246 | 0 |
| K173233 | ReliefBand 1.5 | Reliefband Technologies | 2017-11-30 | 56 | 0 |
| K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017-01-18 | 275 | 0 |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/260 | Well-Life Healthcare Limited | 2017-01-17 | 113 | 0 |
| K160246 | SimulCare II(TM) | Xanacare Technologies, LLC | 2016-10-06 | 248 | 0 |
| K153704 | Strive | Djo, LLC | 2016-06-03 | 163 | 0 |
| K152676 | FD TENS 2090, FD TENS 2095 | Fuji Dynamics , Ltd. | 2016-01-22 | 126 | 0 |
| K152437 | BiowaveHOME Neuromodulation Pain Therapy Device | Biowave Corporation | 2015-09-25 | 29 | 0 |
| K143198 | Synapse Transcutaneous Electrical Stimulation Device | Synapse Electroceutical Limited | 2015-05-27 | 202 | 0 |
| K142666 | Scrambler Therapy MC-5 A Device | Delta International Services & Logistics S.R.L | 2015-05-22 | 246 | 0 |
| K131513 | SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY | Ritm Okb Zao | 2014-07-11 | 409 | 0 |
| K133779 | CP RELIEF WAND | Mid-America Medical Innovations, LLC | 2014-05-30 | 169 | 0 |
| K123099 | Best-AV2 Pro-Sport(tm) | Avazzia, Inc. | 2014-05-23 | 598 | 0 |
| K131675 | BODIHEALTH SYSTEM | Eprt Technologies, Inc. | 2014-03-12 | 278 | 0 |
| K123958 | JIAJIAN POINTOSELECT DIGITAL | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-10-28 | 311 | 0 |
| K130919 | SENSUS | Neurometrix, Inc. | 2013-07-02 | 90 | 0 |
| K122948 | GEM-STIM COMBO STIMULATOR | Gemore Technology Co, Ltd. | 2012-12-21 | 88 | 0 |
| K121369 | NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIM | Ibramed Equipamentos Medicos | 2012-12-19 | 226 | 0 |
| K121305 | STERLING MEDICAL IMPULSE 3 STIMULATOR | Armstrong Industries, Inc. Dha Mediquip Int. Dha S | 2012-09-25 | 147 | 0 |
| K120398 | WITOUCH PRO | Hollywog, LLC | 2012-08-16 | 190 | 0 |
| K121184 | SENSUS | Neurometrix, Inc. | 2012-08-02 | 106 | 0 |
| K121578 | ATOM 1 (MODEL: BRC 2200) | Bioelectric Research Corporation | 2012-07-31 | 62 | 0 |
| K113544 | ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER | Prospera Corporation | 2012-07-27 | 239 | 0 |
| K120569 | GEMORE TENS SYSTEM | Gemore Technology Co, Ltd. | 2012-07-20 | 144 | 0 |
| K120054 | ULTIMA NEO | Pain Management Technologies | 2012-06-05 | 151 | 0 |
| K112288 | JIAJIAN TENS | Wuxi Jiajian Medical Instrument Co., Ltd. | 2012-05-02 | 267 | 0 |
| K111654 | FD TENS 2070 | Fuji Dynamics , Ltd. | 2012-03-01 | 262 | 0 |
| K112258 | NEUROTECH PLUS | Bio-Medical Research, Ltd. | 2012-01-09 | 157 | 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