# Beijing Sunshine E&M Co · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Beijing Sunshine E&M Co · 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 Neck Comforter | Neck Comforter; product code is 84 H - - ST Apparatus, traction, non-powered | 89 K - - NM Device, Pressure Applying; date published is 10/01/2010; address is 42 Yangrouhutong , Beijingshi, Beijing CHINA, verified against its source on 2026-09-16.

- **Firm:** Beijing Sunshine E&M Co _(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:** 42 Yangrouhutong , Beijingshi, Beijing CHINA _(verified: appears in the quote below)_
- **Date published:** 10/01/2010 _(verified: appears in the quote below)_
- **Product code:** 84 H - - ST Apparatus, traction, non-powered | 89 K - - NM Device, Pressure Applying _(verified: each item appears in the quote below)_
- **Product:** Neck Comforter | Neck Comforter _(verified: each item appears in the quote below)_
- **FDA notes:** Class I | Class I _(verified: each item appears in the quote below)_

## What the source says

> Beijing Sunshine E&M Co Date Published : 10/01/2010 42 Yangrouhutong , Beijingshi, Beijing CHINA 84 H - - ST Apparatus, traction, non-powered Date Published: 11/08/2018 Desc: Neck Comforter Notes: Class I 89 K - - NM Device, Pressure Applying Date Published: 10/01/2010 Desc: Neck Comforter Notes: Class I

## 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/).