Data / Medical devices / United States / Remote Smart Health LLC
Remote Smart Health LLC: FDA-registered device maker in Daytona Beach, FL, United States, 10 510(k) clearances
Remote Smart Health LLC is registered with the FDA (registration 3024512705) in Daytona Beach, FL, United States. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 14, 2026. Registered through 2026. 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.
- FDA registration number
- 3024512705
- Address
- 2441 Bellevue Ave, Daytona Beach, FL, United States, 32114
- Owner or operator
- Remote Smart Health LLC (10086044)
- Roles
- Repackager or relabeler
- First device listed
- March 26, 2026
- Registered through
- 2026
- Brand names listed
- Cloviis AI RPM- Smart Bluetooth Corded Arm Blood Pressure Monitor-Large Cuff, Clovis AI RPM, Empirical Health Systems, KismeTruth Remote Patient Monitoring, KismeTruth Remote Patient Monitoring Smart Bluetooth Corded Arm Blood Pressure Monitor-Large Cuff, Remote Smart Health, Remote Smart Health-Smart Bluetooth Corded Arm Blood Pressure Monitor Large Cuff, Smart Diabetes Blood Glucose Monitoring System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 14, 2026 | K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| January 25, 2023 | K223314 | Disposable Blood Lancets | QRK | Substantially Equivalent | Huaian Hening Medical Instruments Co., Ltd. | accessdata.fda.gov |
| March 3, 2019 | K182495 | Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| October 6, 2018 | K182018 | Bluetooth blood pressure monitor | DXN | Substantially Equivalent | Shenzhen Kingyield Technology Co., Ltd. | accessdata.fda.gov |
| March 14, 2018 | K172795 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| November 3, 2017 | K170965 | Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| March 21, 2017 | K152534 | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System | NBW | Substantially Equivalent | Tianjin Empecs Medical Device Co., Ltd. | accessdata.fda.gov |
| April 22, 2016 | K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| June 27, 2014 | K133260 | MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Tianjin Empecs Medical Device Co., Ltd. | accessdata.fda.gov |
| February 28, 2012 | K111456 | MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Tianjin Empecs Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
- All makers of Glucose Oxidase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
Updated May 14, 2026. 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.