Data / Medical devices / China / Polygreen (HK) Co., Ltd.

Polygreen (HK) Co., Ltd.: FDA-registered device maker in Kowloon Hong Kong, China, 8 510(k) clearances

Name: Polygreen (HK) Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Polygreen (HK) Co., Ltd. is registered with the FDA (registration 3001034529) in Kowloon Hong Kong, China. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 15, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3001034529
Address: Unit01, 11/F, Block A, Mai Hing Industrial Building, 16-18 Hing Yip Street, Kwun Tong, Kowloon Hong Kong, China, --
Owner or operator: K-JUMP HEALTH CO., LTD. (9002077)
Roles: Exporter to the US
First device listed: May 23, 2002
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Clinical Electronic Thermometer	SDV	2	Exporter to the US	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Exporter to the US	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	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
March 15, 2013	K121520	ULTRASONIC NEBULIZER (MESH TYPE)	CAF	Substantially Equivalent	K-Jump Health Co., Ltd.	accessdata.fda.gov
October 9, 2009	K092806	AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770	DXN	Substantially Equivalent	K-Jump Health Co., Ltd.	accessdata.fda.gov
June 26, 2009	K083256	ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210	CAF	Substantially Equivalent	K-Jump Health Co., Ltd.	accessdata.fda.gov
June 19, 2009	K083753	SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU	DXN	Substantially Equivalent	K-Jump Health Co., Ltd.	accessdata.fda.gov
July 22, 2005	K051365	COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321	CAF	Substantially Equivalent	K-Jump Health Co., Ltd.	accessdata.fda.gov
September 9, 2003	K032492	BLOOD PRESSURE MONITOR, MODEL KP-7000	DXN	Substantially Equivalent	K-Jump Health Co., Ltd.	accessdata.fda.gov
November 21, 2002	K022916	BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211	DXN	Substantially Equivalent	K-Jump Health Co., Ltd.	accessdata.fda.gov
March 19, 2001	K002665	WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120	DXN	Substantially Equivalent	K-Jump Health Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 15, 2013. 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.