Home / Companies / Everyway Medical Instruments Co.,Ltd

Everyway Medical Instruments Co.,Ltd FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Everyway Medical Instruments Co.,Ltd has 0 FDA recalls, 4 inspections, 29 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Everyway Medical Instruments Co.,Ltd" is on file.

What these totals cover: FDA records filed under the name "Everyway Medical Instruments Co.,Ltd" and its spelling variant "Everyway Medical Instruments Co".

Latest inspection: Aug 12, 2026 · NAI
Latest 510(k): Nov 21, 2025

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	29	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Everyway Medical Instruments Co.,Ltd's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	1	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Reviewing Everyway Medical Instruments Co.,Ltd as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Everyway Medical Instruments Co.,Ltd yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Recent FDA inspections

4 inspections from Jan 20, 2011 to Aug 12, 2026.

Date	Site	Product	Classification	FEI
Aug 12, 2026	New Taipei City, Taiwan	Devices	No Action Indicated (NAI)	3002552319
May 16, 2019	New Taipei City, Taiwan	Devices	Voluntary Action Indicated (VAI)	3002552319
Aug 29, 2013	New Taipei City, Taiwan	Devices	No Action Indicated (NAI)	3002552319
Jan 20, 2011	New Taipei City, Taiwan	Devices	No Action Indicated (NAI)	3002552319

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002552319	New Taipei City, Taiwan	4	Aug 12, 2026

Recent 510(k) clearances

29 510(k) clearances from Jan 24, 2001 to Nov 21, 2025. Showing the 20 most recent. View all 29 510(k) clearances

K-Number	Device	Date
K251856	Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4	Nov 21, 2025
K222488	Everyway Analog OTC TENS	Nov 15, 2022
K213116	Everyway Incontinence Stimulation System	Dec 3, 2021
K202849	Everyway Analog OTC TENS, model N103A/N302	Dec 22, 2020
K202470	Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300	Nov 25, 2020
K202317	Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806	Nov 13, 2020
K201335	Li-Battery powered OTC TENS/EMS Combination Stimulator	Oct 24, 2020
K192589	Everyway OTC TENS/EMS Combination	Dec 19, 2019
K182753	A6 OTC Pain Relief TENS	Oct 26, 2018
K182767	V2 OTC Pain Relief TENS	Oct 26, 2018
K181707	Everyway Wireless TENS & EMS Unit	Sep 26, 2018
K172919	EV-804 OTC Pain Relief TENS	Apr 19, 2018
K173186	S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795…	Feb 28, 2018
K151479	EV-820 OTC Pain Relief TENS	Oct 16, 2015
K142794	Everyway Facial MENS	Jun 2, 2015
K122194	LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE	Apr 4, 2013
K112074	EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800	Feb 1, 2012
K112415	LIFECARE ARM & LEG PAIN RELIEF SYSTEM	Oct 21, 2011
K110716	EVERYWAY LOW BACK PAIN RELIEF SYSTEM	Oct 18, 2011
K103719	LIFECARE CONDUCTIVE GARMENTS	Aug 24, 2011

Everyway Medical Instruments Co.,Ltd and the FDA: common questions

Has Everyway Medical Instruments Co.,Ltd received an FDA warning letter?

No FDA warning letter addressed to the name "Everyway Medical Instruments Co.,Ltd" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Everyway Medical Instruments Co.,Ltd received an FDA Form 483?

FDA has not published a Form 483 for "Everyway Medical Instruments Co.,Ltd" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Everyway Medical Instruments Co.,Ltd?

The most recent FDA inspection on file ended Aug 12, 2026 at New Taipei City, Taiwan and was classified NAI. FDA has 4 inspections of Everyway Medical Instruments Co.,Ltd on file.

Need more than this page shows? Ask about Everyway Medical Instruments Co.,Ltd in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.