FDA Registration
Active
🇺🇸 United States
Remote Smart Health LLC
Reg #: 3024512705
·
FEI: 3024512705
·
Expires 2026
Products
9
Proprietary Names
14
Establishment Types
1
Classifications
9
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- Remote Smart Health LLC
- Registration Number
- 3024512705
- FEI Number
- 3024512705
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2441 Bellevue Ave
- City
- Daytona Beach
- State
- FL
- ZIP
- 32114
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182018
Owner / Operator
- Firm Name
- Remote Smart Health LLC
- Operator Number
- 10086044
- Address
- 124 Lake Grove Road
- City
- Simpsonville
- State
- SC
- Postal Code
- 29681
- Country
- US
- Correspondent
- Victor Trani
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2026-03-26 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2026-03-26 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2026-03-26 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2026-03-26 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2026-03-26 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2026-03-26 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2026-03-26 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2026-03-30 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2026-03-30 |
Proprietary Names
KismeTruth Remote Patient Monitoring
Empirical Health Systems
Clovis AI RPM
Smarthealth1on1
Sunvision Medical
KismeTruth Remote Patient Monitoring Smart Bluetooth Corded Arm Blood Pressure Monitor-Large Cuff
Remote Smart Health-Smart Bluetooth Corded Arm Blood Pressure Monitor Large Cuff
Cloviis AI RPM- Smart Bluetooth Corded Arm Blood Pressure Monitor-Large Cuff
Test n Share
Smart Diabetes Bluetooth Blood Glucose Monitoring System
Test n Share Blood Glucose Monitoring System
Smart Diabetes V Blood Glucose Monitoring System
Smart Diabetes Blood Glucose Monitoring System
Smarthealth1on1 Blood Glucose Monitoring System
Establishment Types
Repack or Relabel Medical Device