FDA Registration Active 🇨🇳 China

Shenzhen Breo Technology Co., Ltd

Reg #: 3006206425 · FEI: 3006206425 · Expires 2026
Products
2
Proprietary Names
14
Establishment Types
1
Classifications
2

Registration Details

Registration Name
Shenzhen Breo Technology Co., Ltd
Registration Number
3006206425
FEI Number
3006206425
Status
Active
Expiry Year
2026
Initial Importer
No
Address
19/F, Hisense Southen Building, No. 1777 Chuangye Road, Nanshan District
City
SHENZHEN Guangdong
Country
CN

Regulatory Submissions

510(k) Number
K242620

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
Phone
931 6254938

Products

Device Name Product Code
Massager, Therapeutic, Electric ISA
Laser, Comb, Hair OAP

Proprietary Names

Breo Laser Hair Growth Comb Scalp 3L Breo Eye Massager: iSee 4, iSee M, EM005, See 7, See 7C, See X3, Care MG 3, Care MG 5; See 7R; Comfy 5 Hand Massager: iPalm 520E, iPalm 520 Pro; WOWO S Breo Scalp3 Scalp Massaging Brush: Scalp 3 breo iDream5S: Dream5S Breo Scalp Trilogy Massager: Scalp 3, Scalp 3S Neck Massager: iNeck 3Pro, Neck S Scalp Massager: Scalp Mini, Scalp 2M, Scalp Mini Pro, Scalp Mini 2 Pulse Pro: GS-110 Head Massager: iDream 3 Breo Massage Gun: Sport-M0220, Sport-M310, Sport-M0500 Foot Massager: FM D191, Relax 5, Relax 3, Foot 3, Foot 3 mini Breo Neck Massager: Neck N5 mini, N6 mini, N7, Neck N1 Pro, N5 mini S3, Z6

Establishment Types

Manufacture Medical Device