Shenzhen Breo Technology Co., Ltd · 89-08 · CHINA
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
- 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
- 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 each item verified
- 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 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html