GUANGZHOU KONMISON · 89-08 · CHINA
For GUANGZHOU KONMISON, import alert is 89-08; country is CHINA; 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 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 2026-09-30.
- 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
— 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
89 I - - SA Massager, Therapeutic, Electric Date Published: 04/08/2025 Desc: 8D HIFU Home Use Massager
— all from 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.