Shenzhen Breo Technology Co., Ltd · 89-08 · CHINA
For Shenzhen Breo 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 ISee108 Eye Massager | IDream3 Eye and Head Massager | iComfort Eye-Z Eye and Temple Massager | IDream3 Eye and Head Massager | iSee4 massager | uCrown Pro Head | iComfort Eye-Z Eye and Temple Massager | iDream 5S Head Massagers | iDream 3 Head Massagers | IDream3 Eye and Head Massager | iSee4 massager | uCrown Pro Head & Eye Massager | iComfort Eye-Z Eye and Temple Massager | uCrown Pro Head | iSee4 massager | ISee108 Eye Massager | IDream3 Eye and Head Massager | iDream 3 Head Massagers | iDream 5S 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 2026-09-30.
- Firm
- Shenzhen Breo 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
- 19/F, Hisense Southen Building, No. 1777 Chuangye Road , Nanshan District , SHENZHEN, GUANGDONG CHINA verified
- Date published
- 02/13/2013 verified
- 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 each item verified
- Product
- ISee108 Eye Massager | IDream3 Eye and Head Massager | iComfort Eye-Z Eye and Temple Massager | IDream3 Eye and Head Massager | iSee4 massager | uCrown Pro Head | iComfort Eye-Z Eye and Temple Massager | iDream 5S Head Massagers | iDream 3 Head Massagers | IDream3 Eye and Head Massager | iSee4 massager | uCrown Pro Head & Eye Massager | iComfort Eye-Z Eye and Temple Massager | uCrown Pro Head | iSee4 massager | ISee108 Eye Massager | IDream3 Eye and Head Massager | iDream 3 Head Massagers | iDream 5S Head Massagers each item verified
- FDA notes
- class II | class II | class II | 12/23/2022 | 12/23/2022 | class II | Class II | Class II | 12/23/2022 | 12/23/2022 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-22
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
84 M - - VV Device, Acupressure Date Published: 03/18/2016 Desc: ISee108 Eye Massager 84 M - - VV Device, Acupressure Date Published: 04/01/2016 Desc: IDream3 Eye and Head Massager 89 I - - RO Vibrator, Therapeutic Date Published: 02/13/2013 Desc: iComfort Eye-Z Eye and Temple Massager Notes: class II 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 - - 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: 10/05/2023 Desc: iDream 5S Head Massagers Notes: 12/23/2022 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: 04/01/2016 Desc: IDream3 Eye and Head Massager 89 I - - RT Pad, Heating, Powered Date Published: 12/16/2015 Desc: iSee4 massager 89 I - - RT Pad, Heating, Powered Date Published: 02/13/2013 Desc: uCrown Pro Head & Eye Massager 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: 02/13/2013 Desc: uCrown Pro Head Notes: Class II 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: 10/05/2023 Desc: iDream 3 Head Massagers Notes: 12/23/2022 89 I - - SA Massager, Therapeutic, Electric Date Published: 10/05/2023 Desc: iDream 5S Head Massagers Notes: 12/23/2022
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html