Company ยท TW
Everyway Medical Instruments Co.,Ltd
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 14 |
| GXY | Electrode, Cutaneous | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 |
| IPF | Stimulator, Muscle, Powered | 3 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 |
| ITH | Equipment, Traction, Powered | 1 |
| LIH | Interferential Current Therapy | 1 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2025 | K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Nov 15, 2022 | K222488 | Everyway Analog OTC TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Dec 3, 2021 | K213116 | Everyway Incontinence Stimulation System Everyway Medical Instruments Co.,Ltd, CN | KPI |
| Dec 22, 2020 | K202849 | Everyway Analog OTC TENS, model N103A/N302 Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Nov 25, 2020 | K202470 | Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 Everyway Medical Instruments Co.,Ltd, CN | NUH |
| Nov 13, 2020 | K202317 | Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 Everyway Medical Instruments Co.,Ltd, CN | NUH |
| Oct 24, 2020 | K201335 | Li-Battery powered OTC TENS/EMS Combination Stimulator Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Dec 19, 2019 | K192589 | Everyway OTC TENS/EMS Combination Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Oct 26, 2018 | K182767 | V2 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Oct 26, 2018 | K182753 | A6 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Sep 26, 2018 | K181707 | Everyway Wireless TENS & EMS Unit Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Apr 19, 2018 | K172919 | EV-804 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Feb 28, 2018 | K173186 | S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & Everyway Medical Instruments Co.,Ltd, TW | GXY |
| Oct 16, 2015 | K151479 | EV-820 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Jun 2, 2015 | K142794 | Everyway Facial MENS Everyway Medical Instruments Co.,Ltd, TW | NFO |
| Apr 4, 2013 | K122194 | LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE Everyway Medical Instruments Co.,Ltd, TW | KPI |
| Feb 1, 2012 | K112074 | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 Everyway Medical Instruments Co.,Ltd | ITH |
| Oct 21, 2011 | K112415 | LIFECARE ARM & LEG PAIN RELIEF SYSTEM Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Oct 18, 2011 | K110716 | EVERYWAY LOW BACK PAIN RELIEF SYSTEM Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Aug 24, 2011 | K103719 | LIFECARE CONDUCTIVE GARMENTS Everyway Medical Instruments Co.,Ltd | GXY |
| Jun 20, 2011 | K110509 | EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 Everyway Medical Instruments Co.,Ltd | LIH |
| Aug 3, 2009 | K083302 | LIFECARE ELECTRODES Everyway Medical Instruments Co.,Ltd | GXY |
| Sep 5, 2007 | K071951 | COMFY SERIES: EV-804, EV-805 & EV-806 Everyway Medical Instruments Co.,Ltd | GZJ |
| Dec 10, 2003 | K033544 | ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 Everyway Medical Instruments Co.,Ltd | IPF |
| Oct 29, 2003 | K033140 | NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P Everyway Medical Instruments Co.,Ltd | IPF |
| Oct 31, 2002 | K020750 | DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS Everyway Medical Instruments Co.,Ltd | IPF |
| Oct 31, 2002 | K020749 | DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS Everyway Medical Instruments Co.,Ltd | GZJ |
| Feb 5, 2002 | K012463 | LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL Everyway Medical Instruments Co.,Ltd, TW | GXY |
| Jan 24, 2001 | K003487 | STIMATE N601 TENS Everyway Medical Instruments Co.,Ltd, TW | GZJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||