Reference Source

SSG (CHINA) · 89-08 · CHINA

For SSG (CHINA), 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 Floatation Capsule; product code is 80 I - - KY Mattress, Flotation Therapy, Non-Powered; date published is 08/14/2017; address is Beijing News Plaza 5th Floor , No. 26 Jianguomen Nei Da Jie , Beijing, Beijing CHINA, verified against its source on 2026-09-30.

Firm
SSG (CHINA) 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
Beijing News Plaza 5th Floor , No. 26 Jianguomen Nei Da Jie , Beijing, Beijing CHINA verified
Date published
08/14/2017 verified
Product code
80 I - - KY Mattress, Flotation Therapy, Non-Powered verified
Product
Floatation Capsule verified
FDA notes
Device Classification unknown. verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

SSG (CHINA) Date Published : 08/14/2017 Beijing News Plaza 5th Floor , No. 26 Jianguomen Nei Da Jie , Beijing, Beijing 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, Product and FDA notes

80 I - - KY Mattress, Flotation Therapy, Non-Powered Date Published: 08/14/2017 Desc: Floatation Capsule Notes: Device Classification unknown.

— all from 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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