Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Everyway Medical Instruments Co.,Ltd — Predicate Candidate Screening

29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

118 daysmedian FDA review time
246 days90th percentile
29clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, ModeEveryway Medical Instruments Co.,Ltd2025-11-211570
K222488Everyway Analog OTC TENSEveryway Medical Instruments Co.,Ltd2022-11-15900
K213116Everyway Incontinence Stimulation SystemEveryway Medical Instruments Co.,Ltd2021-12-03670
K202849Everyway Analog OTC TENS, model N103A/N302Everyway Medical Instruments Co.,Ltd2020-12-22850
K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-Everyway Medical Instruments Co.,Ltd2020-11-25890
K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805,Everyway Medical Instruments Co.,Ltd2020-11-13880
K201335Li-Battery powered OTC TENS/EMS Combination StimulatorEveryway Medical Instruments Co.,Ltd2020-10-241570
K192589Everyway OTC TENS/EMS CombinationEveryway Medical Instruments Co.,Ltd2019-12-19900
K182767V2 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd2018-10-26280
K182753A6 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd2018-10-26280
K181707Everyway Wireless TENS & EMS UnitEveryway Medical Instruments Co.,Ltd2018-09-26900
K172919EV-804 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd2018-04-192060
K173186S Series Electrodes / Models S55105, S80120, SG4040, SG4368,Everyway Medical Instruments Co.,Ltd2018-02-281490
K151479EV-820 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd2015-10-161360
K142794Everyway Facial MENSEveryway Medical Instruments Co.,Ltd2015-06-022460
K122194LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBEEveryway Medical Instruments Co.,Ltd2013-04-042540
K112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800Everyway Medical Instruments Co.,Ltd2012-02-011960
K112415LIFECARE ARM & LEG PAIN RELIEF SYSTEMEveryway Medical Instruments Co.,Ltd2011-10-21600
K110716EVERYWAY LOW BACK PAIN RELIEF SYSTEMEveryway Medical Instruments Co.,Ltd2011-10-182170
K103719LIFECARE CONDUCTIVE GARMENTSEveryway Medical Instruments Co.,Ltd2011-08-242460
K110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908Everyway Medical Instruments Co.,Ltd2011-06-201180
K083302LIFECARE ELECTRODESEveryway Medical Instruments Co.,Ltd2009-08-032660
K071951COMFY SERIES: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd2007-09-05510
K033544ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607Everyway Medical Instruments Co.,Ltd2003-12-10300
K033140NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807PEveryway Medical Instruments Co.,Ltd2003-10-29290
K020750DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EEveryway Medical Instruments Co.,Ltd2002-10-312380
K020749DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EVEveryway Medical Instruments Co.,Ltd2002-10-312380
K012463LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CEveryway Medical Instruments Co.,Ltd2002-02-051880
K003487STIMATE N601 TENSEveryway Medical Instruments Co.,Ltd2001-01-24720

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