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Data / Medical devices / Taiwan / Everyway Medical Instruments Co., Ltd.

Everyway Medical Instruments Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 27 510(k) clearances

Everyway Medical Instruments Co., Ltd. is registered with the FDA (registration 9616877) in New Taipei City, Taiwan. It lists 13 device types. The FDA files 27 510(k) clearances under its listings, the newest dated November 21, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Everyway Medical Instruments Co., Ltd.
FDA registration number
9616877
FEI number
3002552319
Address
3 FL., No. 5, Lane 155, Sec.3 Beishen RD. Shenkeng Dist., New Taipei City, Taiwan, 22203
Owner or operator
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. (9043515)
Roles
Manufacturer
First device listed
November 17, 2007
Registered through
2026
Brand names listed
20035(AXION USA)SG5050, 20089(AXION USA)SG50100, A1, CA100, CA130, CA140, CA160, CA160-W and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, TractionILZ1Manufactureraccessdata.fda.gov
Apparatus, Traction, Non-PoweredHST1Manufactureraccessdata.fda.gov
Chair, With CastersINM1Manufactureraccessdata.fda.gov
Electrode, CutaneousGXY2Manufactureraccessdata.fda.gov
Equipment, Traction, PoweredITH2Manufactureraccessdata.fda.gov
PerineometerHIR2Manufactureraccessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For IncontinenceKPI2Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Manufactureraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Manufactureraccessdata.fda.gov
Stimulator, Transcutaneous Electrical, Aesthetic PurposesNFO2Manufactureraccessdata.fda.gov
Table, PoweredINQ1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 21, 2025K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
November 15, 2022K222488Everyway Analog OTC TENSNUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
December 3, 2021K213116Everyway Incontinence Stimulation SystemKPISubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
December 22, 2020K202849Everyway Analog OTC TENS, model N103A/N302NUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
November 25, 2020K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300NUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
November 13, 2020K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806NUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
October 24, 2020K201335Li-Battery powered OTC TENS/EMS Combination StimulatorNUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
December 19, 2019K192589Everyway OTC TENS/EMS CombinationNUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
September 26, 2018K181707Everyway Wireless TENS & EMS UnitNUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
April 19, 2018K172919EV-804 OTC Pain Relief TENSNUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
February 28, 2018K173186S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75DGXYSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
August 3, 2017K162744Everyway OTC EMS, Model EV-805NGXSubstantially EquivalentEveryway Medical Instrument Co., Ltd.accessdata.fda.gov
July 7, 2017K161349Everyway Incontinence Stimulation SystemKPISubstantially EquivalentEveryway Medical Instrument Co., Ltd.accessdata.fda.gov
October 16, 2015K151479EV-820 OTC Pain Relief TENSNUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
June 2, 2015K142794Everyway Facial MENSNFOSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
April 4, 2013K122194LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBEKPISubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
February 1, 2012K112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800ITHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
October 21, 2011K112415LIFECARE ARM & LEG PAIN RELIEF SYSTEMNUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
October 18, 2011K110716EVERYWAY LOW BACK PAIN RELIEF SYSTEMNUHSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
August 24, 2011K103719LIFECARE CONDUCTIVE GARMENTSGXYSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
August 3, 2009K083302LIFECARE ELECTRODESGXYSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
September 5, 2007K071951COMFY SERIES: EV-804, EV-805 & EV-806GZJSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
December 10, 2003K033544ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607IPFSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
October 29, 2003K033140NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807PIPFSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
October 31, 2002K020749DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENSGZJSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
February 5, 2002K012463LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVALGXYSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov
January 24, 2001K003487STIMATE N601 TENSGZJSubstantially EquivalentEveryway Medical Instruments Co.,Ltdaccessdata.fda.gov

Compare with other makers

Updated November 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.