Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039346136

FEI Number

3039346136

Entity Name

YANKANG MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Taipei, TW

Establishment Address

10F, No. 221, Sec. 4, Zhongxiao E. Rd.,, Taipei 100123, TW

Establishment Type(s)

Foreign Private Label Distributor,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Hong Kong YanKang Medical Limited (Owner Number: 10094533)

Owner / Operator Contact Address

16F, Chinachem Century Tower, 178 Gloucester Road, Wan Chai, HongKong, HK-NOTA 178, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical vibrator therapeutic Instrument Medical vibrator Instrument for therapeutic use Therapeutic massager Data acquisition software for treatment acupoints Data acquisition software for prostate treatment medical applicator and radionuclide system The combination of applicator and radionuclide manual system Software and Implanted mechanical/hydraulic urinary continence device surgical accessories The combination of infrared, near-infrared LEDs, and red light LEDs. Claims the benefits for local heat therapy. The infrared lasers,near-infrared LEDs,red light LEDs,low-level laser therapy-LLLT and photobiomodulation therapy (PBM)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	Class 2	884.5960	2025-12-05
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-12-05
PQQ	Data Acquisition Software	Clinical Chemistry	Class 2	862.2570	2025-12-05
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2025-12-05
QGD	Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories	Gastroenterology, Urology	Class 1	876.5290	2025-12-05
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-12-05

Official Correspondent

HUI-CHIHW Wang

US Agent Details

Howard Huang Email: Best.iso@yahoo.com Phone: (713) 9362358

Related Public Records

Same Entity

Hong Kong YanKang Medical Limited

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973037	Avid N.I.T., Inc.	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	1998-01-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2012	Worldwide Medical Technologies, LLC	1	Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate

Similar Registrations

Registration Number	Establishment Name	Location
3016147813	TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO., LTD.	Tianjin, CN
3013909820	NINGBO LUKE MEDICAL DEVICES CO., LTD.	Yuyao Zhejiang, CN
3012074930	HEARTLAND TECHNOLOGY DONGGUAN CO.,LTD.	Dongguan Guangdong, CN
3042254879	SHENZHEN HONGZHUN ZHIZAO TECHNOLOGY CO., LTD	Shenzhen Guangdong, CN
3023395601	ALL ABOUT INSPIRED COMPANY LIMITED	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039346136. Last updated year: 2026. Please use registration number 3039346136 when referencing this establishment in official correspondence.