# Well-Life Healthcare Limited · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For Well-Life Healthcare Limited · 89-08 · TAIWAN, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is TAIWAN; product is Skeen Patch | Skeen Patch; product code is 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 84 G - - XY Electrode, Cutaneous; date published is 08/02/2023; address is Jhonghe District , No. 168, 6 F; Lide St.; Zhonghe Dist. , New Taipei City, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** Well-Life Healthcare Limited _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** TAIWAN _(verified: appears in the quote below)_
- **Address:** Jhonghe District , No. 168, 6 F; Lide St.; Zhonghe Dist. , New Taipei City, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 08/02/2023 _(verified: appears in the quote below)_
- **Product code:** 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 84 G - - XY Electrode, Cutaneous _(verified: each item appears in the quote below)_
- **Product:** Skeen Patch | Skeen Patch _(verified: each item appears in the quote below)_

## What the source says

> Well-Life Healthcare Limited Date Published : 08/02/2023 Jhonghe District , No. 168, 6 F; Lide St.; Zhonghe Dist. , New Taipei City, TAIWAN 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 08/02/2023 Desc: Skeen Patch 84 G - - XY Electrode, Cutaneous Date Published: 08/02/2023 Desc: Skeen Patch

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).