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Everyway Medical Instruments Co., Ltd.

New Taipei City, TW

EVERYWAY MEDICAL INSTRUMENTS CO., LTD. appears in FDA device records in New Taipei City, TW. FDA records list 29 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
29
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 29 510(k) clearances for Everyway Medical Instruments Co., Ltd. between 2001 and 2025. The busiest year on record is 2018, with 5. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Everyway Medical Instruments Co., Ltd., by decision year
YearClearances
20011
20023
20032
20071
20091
20114
20121
20131
20152
20185
20191
20204
20211
20221
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUHSubstantially Equivalent
K222488Everyway Analog OTC TENSNUHSubstantially Equivalent
K213116Everyway Incontinence Stimulation SystemKPISubstantially Equivalent
K202849Everyway Analog OTC TENS, model N103A/N302NUHSubstantially Equivalent
K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300NUHSubstantially Equivalent
K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806NUHSubstantially Equivalent
K201335Li-Battery powered OTC TENS/EMS Combination StimulatorNUHSubstantially Equivalent
K192589Everyway OTC TENS/EMS CombinationNUHSubstantially Equivalent
K182767V2 OTC Pain Relief TENSNUHSubstantially Equivalent
K182753A6 OTC Pain Relief TENSNUHSubstantially Equivalent
K181707Everyway Wireless TENS & EMS UnitNUHSubstantially Equivalent
K172919EV-804 OTC Pain Relief TENSNUHSubstantially Equivalent
K173186S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75DGXYSubstantially Equivalent
K151479EV-820 OTC Pain Relief TENSNUHSubstantially Equivalent
K142794Everyway Facial MENSNFOSubstantially Equivalent
K122194LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBEKPISubstantially Equivalent
K112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800ITHSubstantially Equivalent
K112415LIFECARE ARM & LEG PAIN RELIEF SYSTEMNUHSubstantially Equivalent
K110716EVERYWAY LOW BACK PAIN RELIEF SYSTEMNUHSubstantially Equivalent
K103719LIFECARE CONDUCTIVE GARMENTSGXYSubstantially Equivalent
K110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908LIHSubstantially Equivalent
K083302LIFECARE ELECTRODESGXYSubstantially Equivalent
K071951COMFY SERIES: EV-804, EV-805 & EV-806GZJSubstantially Equivalent
K033544ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607IPFSubstantially Equivalent
K033140NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807PIPFSubstantially Equivalent
K020750DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMSIPFSubstantially Equivalent
K020749DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENSGZJSubstantially Equivalent
K012463LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVALGXYSubstantially Equivalent
K003487STIMATE N601 TENSGZJSubstantially Equivalent

Registered establishments

FDA registered establishments for Everyway Medical Instruments Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96168773002552319EVERYWAY MEDICAL INSTRUMENTS CO., LTD.3 FL., NO. 5, LANE 155, SEC.3 BEISHEN RD., NEW TAIPEI CITY 22203 TW2026and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain