# SSG (CHINA) · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** CHINA _(verified: appears in the quote below)_
- **Address:** Beijing News Plaza 5th Floor , No. 26 Jianguomen Nei Da Jie , Beijing, Beijing CHINA _(verified: appears in the quote below)_
- **Date published:** 08/14/2017 _(verified: appears in the quote below)_
- **Product code:** 80 I - - KY Mattress, Flotation Therapy, Non-Powered _(verified: appears in the quote below)_
- **Product:** Floatation Capsule _(verified: appears in the quote below)_
- **FDA notes:** Device Classification unknown. _(verified: appears in the quote below)_

## 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.

## 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/).