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Shenzhen Imdk Medical Technology Co., Ltd.: FDA-registered device maker in SHENZHEN Guangdong, China, 7 510(k) clearances

Name: Shenzhen Imdk Medical Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Imdk Medical Technology Co., Ltd. is registered with the FDA (registration 3015007456) in SHENZHEN Guangdong, China. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 11, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015007456
Address: 904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street, Guangming District,518107,Shenzhen,PEOPLE'S REPUBLIC OF CHINA., SHENZHEN Guangdong, China, 518106
Owner or operator: Shenzhen IMDK Medical Technology Co., Ltd. (10058601)
Roles: Exporter to the US, Manufacturer
First device listed: October 13, 2018
Registered through: 2026
Brand names listed: Arm Blood Pressure Monitor (model: BPM-A7), Arm Blood Pressure Monitor (model: BPM-A7L), Arm Blood Pressure Monitor (model: BPM-A7V), Arm Blood Pressure Monitor (model: BPM-A7VL), EMS/TENS Massager Device, Pulse Oximeter (Model C101a2, C101b1, C101a3), Pulse Oximeter ;Model:PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT, Pulse Oximeter C101H1 and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Pressure Cuff	DXQ	2	Manufacturer	accessdata.fda.gov
Monitor, Ultrasonic, Fetal	KNG	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 11, 2026	K252655	Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)	DQA	Substantially Equivalent	Shenzhen Imdk Medical Technology Co., Ltd.	accessdata.fda.gov
February 13, 2026	K253133	Wrist Blood Pressure Monitor (BPM-W1VL)	DXN	Substantially Equivalent	Shenzhen Imdk Medical Technology Co., Ltd.	accessdata.fda.gov
November 26, 2024	K243118	Arm Blood Pressure Monitor (model: BPM-A7VL)	DXN	Substantially Equivalent	Shenzhen Imdk Medical Technology Co., Ltd.	accessdata.fda.gov
February 12, 2024	K233040	EMS/TENS Massager Device	NUH	Substantially Equivalent	Shenzhen Imdk Medical Technology Co., Ltd.	accessdata.fda.gov
October 16, 2022	K221979	Pulse Oximeter (Model C101A2, C101B1, C101A3)	DQA	Substantially Equivalent	Shenzhen Imdk Medical Technology Co., Ltd.	accessdata.fda.gov
August 13, 2018	K173123	Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Imdk Medical Technology Co., Ltd.	accessdata.fda.gov
July 19, 2018	K180419	Ultrasonic Doppler (Model YM-2T8)	KNG	Substantially Equivalent	Shenzhen Imdk Medical Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.