Medical Device Registration

FDA Registration Number: 3013729860

Last Validated: April 25, 2024

Status: Valid

Valid2024 U.S. FDA Medical Device Establishment Registration

MEDHAB, LLC

Establishment Information

1161 Corporate Dr W , Suite 110

Arlington TX, US

1-325-315-2180

jackiebrown@medhab.com

http://www.medhab.com

Official Correspondent

Registrar Corp

144 Research Drive

Hampton VA, USA 23666

+1-757-224-0177

info@registrarcorp.com

www.registrarcorp.com

Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name	Product Code	Status	Last Validated
Oximeter	DQA	Valid	April 24, 2024	Device Listing Device Name Oximeter Product Code DQA Company Function(s) Repackager/Relabeler Proprietary Name(s) MyHeartPlus (pulse-wellue)
Oximeter	DQA	Valid	April 24, 2024	Device Listing Device Name Oximeter Product Code DQA Company Function(s) Repackager/Relabeler Proprietary Name(s) MyHeartPlus (pulse-oxi)
System, Test, Blood Glucose, Over The Counter	NBW	Valid	April 24, 2024	Device Listing Device Name System, Test, Blood Glucose, Over The Counter Product Code NBW Company Function(s) Repackager/Relabeler Proprietary Name(s) iglucose MHP
System, Measurement, Blood-Pressure, Non-Invasive	DXN	Valid	April 24, 2024	Device Listing Device Name System, Measurement, Blood-Pressure, Non-Invasive Product Code DXN Company Function(s) Repackager/Relabeler Proprietary Name(s) teleRPM BPM iblood pressure classic
Analyzer, Body Composition, Exempt	PUH	Valid	April 24, 2024	Device Listing Device Name Analyzer, Body Composition, Exempt Product Code PUH Company Function(s) Repackager/Relabeler Proprietary Name(s) MyHeartPlus (weigh scale XPRO)
System, Test, Blood Glucose, Over The Counter	NBW	Valid	April 24, 2024	Device Listing Device Name System, Test, Blood Glucose, Over The Counter Product Code NBW Company Function(s) Repackager/Relabeler Proprietary Name(s) MyHeartPlus(glucometer)
Oximeter	DQA	Valid	April 24, 2024	Device Listing Device Name Oximeter Product Code DQA Company Function(s) Repackager/Relabeler Proprietary Name(s) ipulseox
Goniometer, Ac-Powered	KQX	Valid	April 24, 2024	Device Listing Device Name Goniometer, Ac-Powered Product Code KQX Company Function(s) Manufacturer Proprietary Name(s) MyNotifi
System, Isokinetic Testing And Evaluation	IKK	Valid	April 24, 2024	Device Listing Device Name System, Isokinetic Testing And Evaluation Product Code IKK Company Function(s) Manufacturer Proprietary Name(s) StepRIte StepRite
System, Measurement, Blood-Pressure, Non-Invasive	DXN	Valid	April 24, 2024	Device Listing Device Name System, Measurement, Blood-Pressure, Non-Invasive Product Code DXN Company Function(s) Repackager/Relabeler Proprietary Name(s) MyHeartPlus (cuff-oxi)
System, Measurement, Blood-Pressure, Non-Invasive	DXN	Valid	April 24, 2024	Device Listing Device Name System, Measurement, Blood-Pressure, Non-Invasive Product Code DXN Company Function(s) Repackager/Relabeler Proprietary Name(s) iblood pressure

Valid2024 U.S. FDA Medical Device Establishment Registration

MEDHAB, LLC

Establishment Information

Official Correspondent

Listings on file with FDA

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