Reference Source

Shanghai Realov Electronic Technology Co Ltd · 89-08 · CHINA

For Shanghai Realov Electronic Technology 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 Renegade Bolero Pump | Renegade Bolero Pump; product code is 78 L - - KY Device, External Penile Rigidity | 85 K - - XQ Vibrator For Therapeutic Use, Genital; date published is 09/28/2017; address is Floor 3 , 799/26 Middle Jia Song Road , Shanghai, Shanghai CHINA, verified against its source on 2026-09-30.

Firm
Shanghai Realov Electronic Technology 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
Floor 3 , 799/26 Middle Jia Song Road , Shanghai, Shanghai CHINA verified
Date published
09/28/2017 verified
Product code
78 L - - KY Device, External Penile Rigidity | 85 K - - XQ Vibrator For Therapeutic Use, Genital each item verified
Product
Renegade Bolero Pump | Renegade Bolero Pump 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

Shanghai Realov Electronic Technology Co Ltd Date Published : 09/28/2017 Floor 3 , 799/26 Middle Jia Song Road , Shanghai, Shanghai 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 and Product

78 L - - KY Device, External Penile Rigidity Date Published: 09/28/2017 Desc: Renegade Bolero Pump 85 K - - XQ Vibrator For Therapeutic Use, Genital Date Published: 09/28/2017 Desc: Renegade Bolero Pump

— 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.

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