Reference Source

Bleosense Technology Co Ltd · 89-08 · HONG KONG SAR

For Bleosense Technology Co Ltd, import alert is 89-08; country is HONG KONG SAR; 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 Finger Rollers; product code is 89 I - - SA Massager, Therapeutic, Electric; date published is 05/29/2015; address is 33 Mong Kok Road , Kowloon, HONG KONG SAR, verified against its source on 2026-09-30.

Firm
Bleosense 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
HONG KONG SAR verified
Address
33 Mong Kok Road , Kowloon, HONG KONG SAR verified
Date published
05/29/2015 verified
Product code
89 I - - SA Massager, Therapeutic, Electric verified
Product
Finger Rollers verified
FDA notes
Class I verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Bleosense Technology Co Ltd Date Published : 05/29/2015 33 Mong Kok Road , Kowloon, HONG KONG SAR

— 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 I - - SA Massager, Therapeutic, Electric Date Published: 05/29/2015 Desc: Finger Rollers Notes: Class I

— 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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