GUANGZHOU KONMISON · 89-08 · CHINA
For GUANGZHOU KONMISON · 89-08 · CHINA, 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 CHINA; product is 8D HIFU Home Use Massager; product code is 89 I - - SA Massager, Therapeutic, Electric; date published is 04/08/2025; address is Kangmeisen No 1 Wa , Guangzhou, CHINA, verified against its source on 2026-09-16.
- Firm
- GUANGZHOU KONMISON 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
- CHINA verified
- Address
- Kangmeisen No 1 Wa , Guangzhou, CHINA verified
- Date published
- 04/08/2025 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric verified
- Product
- 8D HIFU Home Use Massager verified
What the source says
GUANGZHOU KONMISON Date Published : 04/08/2025 Kangmeisen No 1 Wa , Guangzhou, CHINA 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/08/2025 Desc: 8D HIFU Home Use Massager
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.