Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006206425

FEI Number

3006206425

Entity Name

Shenzhen Breo Technology Co., Ltd

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

19/F, Hisense Southen Building, No. 1777 Chuangye Road, Nanshan District, SHENZHEN Guangdong 518056, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Breo Technology Co., Ltd (Owner Number: 9093040)

Owner / Operator Contact Address

19/F, Hisense Southen Building, No. 1777 Chuangye Road, Nanshan District, SHENZHEN, CN-GD 518056, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-12-23
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2024-12-23
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2006-09-29

Official Correspondent

No official correspondent registered.

US Agent Details

CHARLES MACK Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Shenzhen Breo Technology Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006206425. Last updated year: 2026. Please use registration number 3006206425 when referencing this establishment in official correspondence.