Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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