Reference Source

Soft Lines · 89-08 · HONG KONG SAR

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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.

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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