FDA Registration
Active
🇨🇳 China
iPalm 520 Pro; : iPalm 520E; iNeck 3Pro,iNeck 3Pro-a,iNeck 3Pro-b,iNeck 3Pro-c,iNeck 3Pro-d,neck 4a
Reg #: 3006206425
·
FEI: 3006206425
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Breo Technology Co., Ltd
- Registration Number
- 3006206425
- FEI Number
- 3006206425
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 19/F, Hisense Southen Building, No. 1777 Chuangye Road, Nanshan District
- City
- SHENZHEN Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Breo Technology Co., Ltd
- Operator Number
- 9093040
- Address
- 19/F, Hisense Southen Building, No. 1777 Chuangye Road, Nanshan District
- City
- SHENZHEN
- State
- Guangdong
- Postal Code
- 518056
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- CHARLES MACK
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2006-09-29 |
Proprietary Names
iPalm 520 Pro; : iPalm 520E; iNeck 3Pro,iNeck 3Pro-a,iNeck 3Pro-b,iNeck 3Pro-c,iNeck 3Pro-d,neck 4a
EM005
Sport-M0210;BM 2001S;MG2;MMP-100; neck 2b1;iSee M;see m1;see m2;see m3;see m4;see m5;see m6;breo Neck P4
Neck N5 mini
OS112 uGalaxy; OS190 uScalp 2; Scalp Mini Pro;Scalp Mini,Scalp 2M,Scalp 2C,Scalp 2S; Scalp mini 2
iDream 3, iDream 5s
Scalp 3
Scalp 3L
Neck C2-X; wowo s, WOWO S, WOWO SU, WOWO SE;906Q; EM001; EM002; iSee 3S; FM D191
N6 mini; Z6; Y2; Y3
FMD191R
Sport-M0220
Establishment Types
Manufacture Medical Device