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Data / Medical devices / United States / Home Health Us Incorporated

Home Health Us Incorporated: FDA-registered device maker in Sarasota, FL, United States, 11 510(k) clearances

Home Health Us Incorporated is registered with the FDA (registration 3021186226) in Sarasota, FL, United States. It lists 53 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 4, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Home Health Us Incorporated
FDA registration number
3021186226
Address
7672 15th St E, Sarasota, FL, United States, 34243
Owner or operator
Home Health US Inc (10083434)
Roles
Complaint file establishment
First device listed
November 19, 2021
Registered through
2027
Brand names listed
ELDONCARD, One Step, One Step Infrared Thermometer DET-3017, One Step®

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)JMA1Complaint file establishmentaccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Complaint file establishmentaccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Complaint file establishmentaccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Complaint file establishmentaccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Complaint file establishmentaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Complaint file establishmentaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishmentaccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Complaint file establishmentaccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Complaint file establishmentaccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Complaint file establishmentaccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUComplaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Complaint file establishmentaccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Complaint file establishmentaccessdata.fda.gov
Immunoassay, Pregnanediol Glucuronide, Over The CounterQKE1Complaint file establishmentaccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Complaint file establishmentaccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Complaint file establishmentaccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Complaint file establishmentaccessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use OnlyQRL2Complaint file establishmentaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Complaint file establishmentaccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Complaint file establishmentaccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBUComplaint file establishmentaccessdata.fda.gov
Paper, Obstetric PhLNW1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant DrugsLFG2Complaint file establishmentaccessdata.fda.gov
Reagent, Occult BloodKHE2Complaint file establishmentaccessdata.fda.gov
Refractometer For Clinical UseJRE1Complaint file establishmentaccessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureQRK2Complaint file establishmentaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Complaint file establishmentaccessdata.fda.gov
System, Test, Automated Blood Grouping And AntibodyKSZ2Complaint file establishmentaccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Complaint file establishmentaccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Complaint file establishmentaccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Complaint file establishmentaccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Complaint file establishmentaccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Complaint file establishmentaccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Complaint file establishmentaccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Complaint file establishmentaccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Complaint file establishmentaccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Complaint file establishmentaccessdata.fda.gov
Test, Morphine, Over The CounterNGI2Complaint file establishmentaccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Complaint file establishmentaccessdata.fda.gov
Test, Phencyclidine (Pcp), Over The CounterNGMUComplaint file establishmentaccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Complaint file establishmentaccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Complaint file establishmentaccessdata.fda.gov
Test, Urine LeukocyteLJX1Complaint file establishmentaccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Complaint file establishmentaccessdata.fda.gov
Thin Layer Chromatography, MorphineDNK2Complaint file establishmentaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 4, 2024K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)DXNSubstantially EquivalentShenzhen Finicare Co., Ltd.accessdata.fda.gov
September 27, 2024K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
June 21, 2024K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamLCXSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov
May 10, 2024K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJGSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov
September 20, 2023K230043Insulin Pen NeedleFMISubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
November 30, 2022K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceQRLSubstantially EquivalentShandong Lianfa Medical Plastic Products Co. , Ltd.accessdata.fda.gov
March 27, 2019K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)DKZSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
October 29, 2018K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLLSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
May 23, 2018K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJILSubstantially EquivalentDFI Co., Ltd.accessdata.fda.gov
September 14, 2011K110309FOB ONE STEP RAPID TESTKHESubstantially EquivalentOrient Gene Biotechaccessdata.fda.gov
May 4, 1979K790282ELDONCARDKSZSubstantially EquivalentNordisk Infuser Systemaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
July 25, 202597350Class IIIOngoingOne Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side Due to incorrect/lack of Unique Device Identifier (UDI) codes.accessdata.fda.gov

Compare with other makers

Updated October 21, 2025. 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.