Beijing Sunshine E&M Co · 89-08 · CHINA
For Beijing Sunshine E&M Co, 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html