Reference Source

Olivashow Co Limited · 89-08 · CHINA

For Olivashow Co Limited, 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 Plastic Cupping Set Breast Enlargement Cup | Plastic Cupping Set Breast Enlargement Cup | Plastic Cupping Set Breast Enlargement Cup; product code is 79 M - - WZ Expander, Breast, External | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric; date published is 07/13/2012; address is Room 703 Bldg 7 Of Tong Tai Garden , Wenzhou Zhejiang, CHINA, verified against its source on 2026-09-30.

Firm
Olivashow Co Limited 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
Room 703 Bldg 7 Of Tong Tai Garden , Wenzhou Zhejiang, CHINA verified
Date published
07/13/2012 verified
Product code
79 M - - WZ Expander, Breast, External | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric each item verified
Product
Plastic Cupping Set Breast Enlargement Cup | Plastic Cupping Set Breast Enlargement Cup | Plastic Cupping Set Breast Enlargement Cup each item verified
FDA notes
Class II | class II | class II each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Olivashow Co Limited Date Published : 07/13/2012 Room 703 Bldg 7 Of Tong Tai Garden , Wenzhou Zhejiang, 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

79 M - - WZ Expander, Breast, External Date Published: 07/13/2012 Desc: Plastic Cupping Set Breast Enlargement Cup Notes: Class II 89 I - - PF Stimulator, Muscle, Powered Date Published: 07/13/2012 Desc: Plastic Cupping Set Breast Enlargement Cup Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 07/13/2012 Desc: Plastic Cupping Set Breast Enlargement Cup Notes: class II

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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.