Everyway Medical Instruments Co.,Ltd: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Everyway Medical Instruments Co.,Ltd” (first 2001, latest 2025), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 118 days. Since 2017 the median was 90 days, against 146 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 196 |
| 2013 | 1 | 254 |
| 2014 | 0 | — |
| 2015 | 2 | 191 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 5 | 90 |
| 2019 | 1 | 90 |
| 2020 | 4 | 88 |
| 2021 | 1 | 67 |
| 2022 | 1 | 90 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 157 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Everyway Medical Instruments Co.,Ltd took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 14 | 14 |
| GXY | Electrode, Cutaneous | 4 | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | 2 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
| LIH | Interferential Current Therapy | 1 | 1 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
Review panels
Most recent Everyway Medical Instruments Co.,Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | NUH | 2025-11-21 | 157 |
| K222488 | Everyway Analog OTC TENS | NUH | 2022-11-15 | 90 |
| K213116 | Everyway Incontinence Stimulation System | KPI | 2021-12-03 | 67 |
| K202849 | Everyway Analog OTC TENS, model N103A/N302 | NUH | 2020-12-22 | 85 |
| K202470 | Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 | NUH | 2020-11-25 | 89 |
| K202317 | Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 | NUH | 2020-11-13 | 88 |
| K201335 | Li-Battery powered OTC TENS/EMS Combination Stimulator | NUH | 2020-10-24 | 157 |
| K192589 | Everyway OTC TENS/EMS Combination | NUH | 2019-12-19 | 90 |
| K182767 | V2 OTC Pain Relief TENS | NUH | 2018-10-26 | 28 |
| K182753 | A6 OTC Pain Relief TENS | NUH | 2018-10-26 | 28 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Everyway Medical Instruments Co.,Ltd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Everyway Medical Instruments Co.,Ltd (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Everyway Medical Instrument Co., Ltd. (2 510(k)s)
- Everyway Medical Instruments Co., Ldt. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Everyway Medical Instruments Co.,Ltd?
FDA lists 29 510(k) clearances under the applicant name “Everyway Medical Instruments Co.,Ltd” (first 2001, latest 2025), across 8 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Everyway Medical Instruments Co.,Ltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Everyway Medical Instruments Co.,Ltd is 118 days. Since 2017: 90 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Everyway Medical Instruments Co.,Ltd?
The most frequent FDA product codes under this applicant name are NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 14); GXY (Electrode, Cutaneous, 4); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3).
Next steps
- See all 29 Everyway Medical Instruments Co.,Ltd clearances with predicates and recalls
- Run predicate analysis for product code NUH, Everyway Medical Instruments Co.,Ltd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.