# Shenzhen Breo Technology Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenzhen Breo Technology 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 IDream3 Eye and Head Massager | ISee108 Eye Massager | IDream3 Eye and Head Massager | iSee4 massager | uCrown Pro Head | iComfort Eye-Z Eye and Temple Massager | iSee4 massager | iDream 3 Head Massagers | iDream 5S Head Massagers | iComfort Eye-Z Eye and Temple Massager | uCrown Pro Head & Eye Massager | IDream3 Eye and Head Massager | iDream 5S Head Massagers | iSee4 massager | ISee108 Eye Massager | IDream3 Eye and Head Massager | uCrown Pro Head | iComfort Eye-Z Eye and Temple Massager | iDream 3 Head Massagers; product code is 84 M - - VV Device, Acupressure | 84 M - - VV Device, Acupressure | 89 I - - RO Vibrator, Therapeutic | 89 I - - RO Vibrator, Therapeutic | 89 I - - RO Vibrator, Therapeutic | 89 I - - RO Vibrator, Therapeutic | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric; date published is 02/13/2013; address is 19/F, Hisense Southen Building, No. 1777 Chuangye Road , Nanshan District , SHENZHEN, GUANGDONG CHINA, verified against its source on 2026-09-16.

- **Firm:** Shenzhen Breo 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:** CHINA _(verified: appears in the quote below)_
- **Address:** 19/F, Hisense Southen Building, No. 1777 Chuangye Road , Nanshan District , SHENZHEN, GUANGDONG CHINA _(verified: appears in the quote below)_
- **Date published:** 02/13/2013 _(verified: appears in the quote below)_
- **Product code:** 84 M - - VV Device, Acupressure | 84 M - - VV Device, Acupressure | 89 I - - RO Vibrator, Therapeutic | 89 I - - RO Vibrator, Therapeutic | 89 I - - RO Vibrator, Therapeutic | 89 I - - RO Vibrator, Therapeutic | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - RT Pad, Heating, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** IDream3 Eye and Head Massager | ISee108 Eye Massager | IDream3 Eye and Head Massager | iSee4 massager | uCrown Pro Head | iComfort Eye-Z Eye and Temple Massager | iSee4 massager | iDream 3 Head Massagers | iDream 5S Head Massagers | iComfort Eye-Z Eye and Temple Massager | uCrown Pro Head & Eye Massager | IDream3 Eye and Head Massager | iDream 5S Head Massagers | iSee4 massager | ISee108 Eye Massager | IDream3 Eye and Head Massager | uCrown Pro Head | iComfort Eye-Z Eye and Temple Massager | iDream 3 Head Massagers _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II | 12/23/2022 | 12/23/2022 | class II | class II | 12/23/2022 | Class II | Class II | 12/23/2022 _(verified: each item appears in the quote below)_

## What the source says

> Shenzhen Breo Technology Co., Ltd Date Published : 02/13/2013 19/F, Hisense Southen Building, No. 1777 Chuangye Road , Nanshan District , SHENZHEN, GUANGDONG CHINA 84 M - - VV Device, Acupressure Date Published: 04/01/2016 Desc: IDream3 Eye and Head Massager 84 M - - VV Device, Acupressure Date Published: 03/18/2016 Desc: ISee108 Eye Massager 89 I - - RO Vibrator, Therapeutic Date Published: 04/01/2016 Desc: IDream3 Eye and Head Massager 89 I - - RO Vibrator, Therapeutic Date Published: 12/16/2015 Desc: iSee4 massager 89 I - - RO Vibrator, Therapeutic Date Published: 02/13/2013 Desc: uCrown Pro Head Notes: class II 89 I - - RO Vibrator, Therapeutic Date Published: 02/13/2013 Desc: iComfort Eye-Z Eye and Temple Massager Notes: class II 89 I - - RT Pad, Heating, Powered Date Published: 12/16/2015 Desc: iSee4 massager 89 I - - RT Pad, Heating, Powered Date Published: 10/05/2023 Desc: iDream 3 Head Massagers Notes: 12/23/2022 89 I - - RT Pad, Heating, Powered Date Published: 10/05/2023 Desc: iDream 5S Head Massagers Notes: 12/23/2022 89 I - - RT Pad, Heating, Powered Date Published: 02/13/2013 Desc: iComfort Eye-Z Eye and Temple Massager Notes: class II 89 I - - RT Pad, Heating, Powered Date Published: 02/13/2013 Desc: uCrown Pro Head & Eye Massager Notes: class II 89 I - - RT Pad, Heating, Powered Date Published: 04/01/2016 Desc: IDream3 Eye and Head Massager 89 I - - SA Massager, Therapeutic, Electric Date Published: 10/05/2023 Desc: iDream 5S Head Massagers Notes: 12/23/2022 89 I - - SA Massager, Therapeutic, Electric Date Published: 12/16/2015 Desc: iSee4 massager 89 I - - SA Massager, Therapeutic, Electric Date Published: 03/18/2016 Desc: ISee108 Eye Massager 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/01/2016 Desc: IDream3 Eye and Head Massager 89 I - - SA Massager, Therapeutic, Electric Date Published: 02/13/2013 Desc: uCrown Pro Head Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 02/13/2013 Desc: iComfort Eye-Z Eye and Temple Massager Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 10/05/2023 Desc: iDream 3 Head Massagers Notes: 12/23/2022

## 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/).