Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043709874

FEI Number

3043709874

Entity Name

BRAIN HEALTH SPECTRUM (CHENGDU) ARTIFICIAL INTELLIGENCE TECHNOLOGY CO., LTD.

City/State/Country

Chengdu Sichuan, CN

Establishment Address

No. 9, 1st Floor, Building 27, No. 1388, Longxiang Street, Xinglong Subdistrict, Tianfu New Area, Chengdu Sichuan 610200, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Brain Health Spectrum (Chengdu) Artificial Intelligence Tech (Owner Number: 10095091)

Owner / Operator Contact Address

No. 9, 1st Floor, Building 27, No. 1388, Longxiang Street, Xinglong Subdistrict, Tianfu New Area, Chengdu, CN-SC 610200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TOOTHBRUSH, POWERED IRRIGATOR, POWERED NASAL EMS beauty device Ion beauty device Red light heatable shoulder massage device Shoulder massage device Eye massage device Massage Facial Beauty Instrument Electric Massage Red light heatable neck massage device Hand massage device Neck massage device Waist massage device FACE & BODYSCULPTING MASSAGER Massage bed Eyes Beauty Instrument Leg massage device Red light heatable leg massage device Hip massage device Massage mat Headrest massage device Massager, therapeutic, electric, Gua sha, EMS, Therapeutic warmth, cold, Red LED Light, Blue LED Light, Purple Led Light Hot&cold Beauty Instrument Head massage device Knee massager Massage chair Electric Neck Beauty Instrument Red light heatable waist massage device Foot massage device Massage pillow Abdominal massage device Massage beauty device LED hair growth cap Red light beauty device red light product for nose Red light lamp Red light physiotherapy vest Red light yoga pad Photon beauty mask Red light blanket Red light sleeping bag Red light treatment cap Light energy beauty device Red light pain reliever Red light mask Blue light panel Red light wrist protector Red light belt USB red light ear therapy Red light hair growth cap Red light shoes Infrared near-infrared mask red light peoducts Red light horse head Red light panel Pet red light leg protector Red light bed LED irradiation lamp Red light knee protector Red light physiotherapy pad Red light treatment stick Red light physiotherapy chamber Radiofrequency beauty device Red light hand protector Laser hair growth cap Red light shoulder protector Red light silicone mask Red light stick beauty device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2026-01-23
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2026-01-23
HPO	Magnet, Ac-Powered	Ophthalmic	Class 2	886.4440	2026-01-23
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2026-01-23
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2026-01-23
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-01-23

Official Correspondent

Siqi Yang

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Brain Health Spectrum (Chengdu) Artificial Intelligence Tech

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043709874. Last updated year: 2026. Please use registration number 3043709874 when referencing this establishment in official correspondence.