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Medhab, LLC: FDA-registered device maker in Arlington, TX, United States, 5 510(k) clearances

Name: Medhab, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medhab, LLC is registered with the FDA (registration 3013729860) in Arlington, TX, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 20, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013729860
Address: 1161 Corporate Dr W, Suite 110, Arlington, TX, United States, 76006
Owner or operator: MEDHAB LLC (10057976)
Roles: Manufacturer, Repackager or relabeler
First device listed: June 20, 2018
Registered through: 2026
Brand names listed: MHP-CUFFJUM, MyHeartPlus (cuff-oxi), MyHeartPlus (pulse-oxi), MyHeartPlus (pulse-wellue), MyHeartPlus (weigh scale XPRO), MyHeartPlus(glucometer), MyNotifi, StepRIte and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Body Composition, Exempt	PUH	2	Repackager or relabeler	accessdata.fda.gov
Goniometer, Ac-Powered	KQX	1	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
System, Isokinetic Testing And Evaluation	IKK	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Repackager or relabeler	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 20, 2020	K191657	Bioland Blood Glucose Monitoring System	NBW	Substantially Equivalent	Bioland Technology, Ltd.	accessdata.fda.gov
November 27, 2019	K191673	Upper Arm Blood Pressure Monitor	DXN	Substantially Equivalent	Famidoc Technology Company Limited	accessdata.fda.gov
March 3, 2019	K182495	Electronic Blood Pressure Monitor	DXN	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
August 13, 2018	K173123	Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Imdk Medical Technology Co., Ltd.	accessdata.fda.gov
October 3, 2013	K130947	FINGERTIP PULSE OXIMETER	DQA	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 20, 2020. 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.