Beijing Sunshine E&M Co · 89-08 · CHINA
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
- 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
- 42 Yangrouhutong , Beijingshi, Beijing CHINA verified
- Date published
- 10/01/2010 verified
- Product code
- 84 H - - ST Apparatus, traction, non-powered | 89 K - - NM Device, Pressure Applying each item verified
- Product
- Neck Comforter | Neck Comforter each item verified
- FDA notes
- Class I | Class I each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.