Well-Life Healthcare Limited · 89-08 · TAIWAN
For Well-Life Healthcare Limited, import alert is 89-08; country is TAIWAN; 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)"; 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 2026-09-30.
- Firm
- Well-Life Healthcare Limited verified
- 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
- Address
- Jhonghe District , No. 168, 6 F; Lide St.; Zhonghe Dist. , New Taipei City, TAIWAN verified
- Date published
- 08/02/2023 verified
- Product code
- 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 84 G - - XY Electrode, Cutaneous each item verified
- Product
- Skeen Patch | Skeen Patch each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html