Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007134734

FEI Number

3007134734

Entity Name

FORA CARE INC.

City/State/Country

Moorpark, CA, US

Establishment Address

893 Patriot Dr Ste D, Moorpark, CA 93021, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Fora Care Inc. (Owner Number: 10026431)

Owner / Operator Contact Address

893 Patriot Dr., Suite D, Moorpark, CA 93021, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201549

PMA Number

N/A

All Registered Proprietary Names

FORA P50 Blood Pressure Monitoring System Health Care System Software FORA FORA V30 ForaCare V30 FORA gojji LANCING DEVICE ; FORA gojji STERILE LANCETS FORA LANCING DEVICE ; FORA STERILE LANCETS FORA G30 FORA G30a FORA P20 Blood Pressure Monitoring System FORA HM100 TD-2202 FORA GTel Blood Glucose Monitoring System FORA GTel Multi-Functional Monitoring System gojji Multi-Functional Monitoring System ForacCare Premium V10 FORA G20 lancet FORA Safety Lancet TN'G SpO2 FORA O2 Fingertip PulseOximeter FORA D20 Blood Glucose plus Blood Pressure Monitoring System FORA Test N'GO Advance Total Cholesterol Test System FORA Test N'GO Advance Voice Total Cholesterol Test System FORA Control Solution FORA Spiro10b Peak Flow Meter FORA TELEHEALTH SYSTEM TD-8002 FORA FORA SAFETY LANCET-ROUND (Sterile) TD-4258 ForaCare FORA POCT S10 FORA G90 FORA G90 Perform FORA G73 FORA G70 FORA G72 TN'G BP FORA TN'G BP Blood Pressure Monitoring System FORA GTel Multi-Functional Monitoring System FORA Test N'GO Advance Pro Multi-Functional Monitoring System gojji Multi-Functional Monitoring System FORA G31a FORA G31 ForaCare Wisdom D40d POCT FORA FORA TN'G Blood Glucose Monitoring System ForaCare Diamond Mini FORA DIAMOND MINI, DM30 FORA DIAMOND PRIMA, DM10 ForaCare Diamond PrimaI FORA Test N'GO Voice Blood Glucose Monitoring System FORA TN'G Voice Blood Glucose Monitoring System FORA GD50 Blood Glucose Monitoring System TD-4272 FORA ForaCare GD40 FORA Disposable Surgical Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-03-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-07-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-07-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-07-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-01-12
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-01-12
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-01-30
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2023-01-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-01-12
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-01-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-11-08
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2011-07-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2018-09-03
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-12-27
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-12-27
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-01-12
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-01-12
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2015-05-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-03-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-01-12
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-01-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-01-12
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2021-03-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-11-08
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2024-08-12
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2011-01-12
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2011-07-13
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-06-23
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-07-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-01-12
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-01-12
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-08-18
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-08-18
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-01-12
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-01-12
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-01-12
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-01-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-04-28
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2018-09-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-09-03
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-09-03
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2018-09-03
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-01-12
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-01-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-12-27
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-12-27
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-12-27
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2011-07-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-07-13
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-02-23
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-02-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-12-09
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-12-09
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-12-09
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-07-13
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-07-13
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-10-22

Official Correspondent

G.L. Liu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fora Care Inc.

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

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3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007134734. Last updated year: 2026. Please use registration number 3007134734 when referencing this establishment in official correspondence.