Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013729860

FEI Number

3013729860

Entity Name

MEDHAB, LLC

City/State/Country

Arlington, TX, US

Establishment Address

1161 Corporate Dr W , Suite 110, Arlington, TX 76006, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MEDHAB LLC (Owner Number: 10057976)

Owner / Operator Contact Address

1161 Corporate Dr W, Suite 110, Arlington, TX 76006, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130947

PMA Number

N/A

All Registered Proprietary Names

MyNotifi StepRite StepRIte MHP-CUFFJUM MyHeartPlus (cuff-oxi) MyHeartPlus(glucometer) MyHeartPlus (pulse-oxi) MyHeartPlus (pulse-wellue)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQX	Goniometer, Ac-Powered	Orthopedic	Class 1	888.1500	2018-06-20
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	Class 2	890.1925	2019-09-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-08-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-05-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2022-05-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-05-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-05-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDHAB LLC

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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

Similar Registrations

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3017264244	DJO, LLC	Carlsbad, CA, US
3022375812	BIOINTERACTIVE TECHNOLOGIES INC.	Vancouver British Columbia, CA
3009718162	OPED GmbH	Valley/Oberlaindern Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013729860. Last updated year: 2026. Please use registration number 3013729860 when referencing this establishment in official correspondence.