Reference Source

SSG (CHINA) · 89-08 · CHINA

For SSG (CHINA) · 89-08 · CHINA, 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 CHINA; 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 2026-09-16.

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

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

Source

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