Reference Source

Zhangjiangang Yayang International Co., Ltd. · 89-08 · CHINA

For Zhangjiangang Yayang International Co., Ltd. · 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 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 2026-09-16.

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 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

accessdata.fda.gov, retrieved 2026-09-15

Source

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