Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019778249

FEI Number

3019778249

Entity Name

SHENZHEN MEI ZHI GUANG DIAN LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

301 and 101, Building D, Jingtie Industrial Park, No. 49, Changjiang Pu Road, Heao Community, Yuanshan Street,, Shenzhen, 518115, Guangdong, China, Shenzhen Guangdong 518115, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHENZHEN MEI ZHI GUANG DIAN LIMITED (Owner Number: 10094450)

Owner / Operator Contact Address

301 and 101, Building D, Jingtie Industrial Park, No. 49, Changjiang Pu Road, Heao Community, Yuanshan Street,, Shenzhen, 518115, Guangdong, China, Shenzhen, CN-GD 518115, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Portabl therapy Light (EmberGO-30; EmberGo+; EmberGo-R; EmberGo-B; EmberGo-G; EmberGo-Y; EmberGo-4-in-1; EmberGo-2-in-1) LED Red Physical therapy cap(Ember-Crown) LED Red therapy Light ( Ember-Mini ) LED Red therapy Light (EmberPRO-50; EmberPRO-100; EmberPRO-200; EmberPRO-300; EmberPRO-650; ) LED Red Physical therapy blanket (Ember-Pod) LED therapy Light ( Ember-Tab; Ember-TabX; ) LED Red Physical therapy Girdle (Ember-Wrap ) LED therapy Light(EmberPRO+50; EmberPRO+100; EmberPRO+200; EmberPRO+300; EmberPRO+650; )

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-12-01

Official Correspondent

baolin qin

US Agent Details

Nelson Xie Business: WISELINK MEDICAL INC. Email: nelson.xie@wiselinkus.com Phone: (631) 2558110

Related Public Records

Same Entity

SHENZHEN MEI ZHI GUANG DIAN LIMITED

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 3019778249. Last updated year: 2026. Please use registration number 3019778249 when referencing this establishment in official correspondence.