Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005280264

FEI Number

3005280264

Entity Name

HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD.

City/State/Country

HARBIN Heilongjiang, CN

Establishment Address

42-1 LANE 2, JING WEI STREET, DAOLI DISTRICT,, HARBIN Heilongjiang 150010, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD. (Owner Number: 9038949)

Owner / Operator Contact Address

42-1 LANE 2, JING WEI STREET, DAOLI DISTRICT, HARBIN, HarBin, CN-HL 150010, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141892

PMA Number

N/A

All Registered Proprietary Names

QK-Therapeutic Apparatus model:QK-C02F,QK-S06 QK-Therapeutic Apparatus,model:QK-C01A,QK-C01B,QK-C01CZ,QK-C01EZ.QK-S14.QK-C02FZ,QK-C02D QK-Therapeutic Apparatus,model:QK-S05,QK-S07,QK-S08,QK-S09.QK-S10,QK-S15

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	2015-03-23

Official Correspondent

XIANGLIN WANG

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005280264. Last updated year: 2026. Please use registration number 3005280264 when referencing this establishment in official correspondence.