Zhangjiangang Yayang International Co., Ltd. · 89-08 · CHINA
For Zhangjiangang Yayang International Co., Ltd., 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 BODY BACK STICKS - PLASTIC MANUAL MASSAGERS; product code is 89 L - - YG Massager, Therapeutic, Manual; date published is 11/19/2015; address is NO. 3 Jinxiulu , Zhangjiagang , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-30.
- Firm
- Zhangjiangang Yayang International Co., Ltd. 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
- NO. 3 Jinxiulu , Zhangjiagang , Suzhou, Jiangsu CHINA verified
- Date published
- 11/19/2015 verified
- Product code
- 89 L - - YG Massager, Therapeutic, Manual verified
- Product
- BODY BACK STICKS - PLASTIC MANUAL MASSAGERS verified
- FDA notes
- The device has no 510(k) clearance verified
What the source says
Zhangjiangang Yayang International Co., Ltd. Date Published : 11/19/2015 NO. 3 Jinxiulu , Zhangjiagang , Suzhou, Jiangsu 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
89 L - - YG Massager, Therapeutic, Manual Date Published: 11/19/2015 Desc: BODY BACK STICKS - PLASTIC MANUAL MASSAGERS Notes: The device has no 510(k) clearance
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html