Soft Lines · 89-08 · HONG KONG SAR
For Soft Lines, import alert is 89-08; country is HONG KONG SAR; 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 code is 78 M - - NW Analyzer, Body Composition; date published is 09/16/2009; address is 1 Science Museum Road , Tsim Sha Tsui, Kowloon HONG KONG SAR, verified against its source on 2026-09-30.
- Firm
- Soft Lines 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
- HONG KONG SAR verified
- Address
- 1 Science Museum Road , Tsim Sha Tsui, Kowloon HONG KONG SAR verified
- Date published
- 09/16/2009 verified
- Product code
- 78 M - - NW Analyzer, Body Composition verified
- FDA notes
- Emjoi Body Fat Monitor AP-30 (Body Composition Analyzer) 8/26/2003. Lack of 510(k) Approval. verified
What the source says
Soft Lines Date Published : 09/16/2009 1 Science Museum Road , Tsim Sha Tsui, Kowloon HONG KONG SAR
— 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 FDA notes
78 M - - NW Analyzer, Body Composition Date Published: 11/08/2018 Notes: Emjoi Body Fat Monitor AP-30 (Body Composition Analyzer) 8/26/2003. Lack of 510(k) Approval.
— 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.