# Bleosense Technology Co Ltd · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

For Bleosense Technology Co Ltd · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; 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 2026-09-16.

- **Firm:** Bleosense Technology Co Ltd _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 33 Mong Kok Road , Kowloon, HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 05/29/2015 _(verified: appears in the quote below)_
- **Product code:** 89 I - - SA Massager, Therapeutic, Electric _(verified: appears in the quote below)_
- **Product:** Finger Rollers _(verified: appears in the quote below)_
- **FDA notes:** Class I _(verified: appears in the quote below)_

## What the source says

> Bleosense Technology Co Ltd Date Published : 05/29/2015 33 Mong Kok Road , Kowloon, HONG KONG SAR 89 I - - SA Massager, Therapeutic, Electric Date Published: 05/29/2015 Desc: Finger Rollers Notes: Class I

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).