# Soft Lines · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

For Soft Lines · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; 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 2026-09-16.

- **Firm:** Soft Lines _(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:** HONG KONG SAR _(verified: appears in the quote below)_
- **Address:** 1 Science Museum Road , Tsim Sha Tsui, Kowloon HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 78 M - - NW Analyzer, Body Composition _(verified: appears in the quote below)_
- **FDA notes:** Emjoi Body Fat Monitor AP-30 (Body Composition Analyzer) 8/26/2003. Lack of 510(k) Approval. _(verified: appears in the quote below)_

## What the source says

> Soft Lines Date Published : 09/16/2009 1 Science Museum Road , Tsim Sha Tsui, Kowloon HONG KONG SAR 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.

## 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/).