Data / Medical devices / United States / Leraise Health International LLC
Leraise Health International LLC: FDA-registered device maker in Dover, DE, United States, 3 510(k) clearances
Leraise Health International LLC is registered with the FDA (registration 3045492872) in Dover, DE, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045492872
- Address
- 8 The Grn Ste 1, Dover, DE, United States, 19901
- Owner or operator
- Leraise Health International LLC (10095962)
- Roles
- Complaint file establishment
- First device listed
- May 30, 2026
- Registered through
- 2026
- Brand names listed
- Blood Glucose Monitoring System, Blood Glucose Meter and Test Strips Kit; model: 513S, Electronic Blood Pressure Monitor; model: B13A, Electronic Blood Pressure Monitor; model: TMB-1117-SN
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| March 19, 2024 | K233146 | Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Jamr Technology Co., Ltd. | accessdata.fda.gov |
| December 20, 2023 | K233130 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| October 13, 2017 | K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | NBW | Substantially Equivalent | All Medicus Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of System, Test, Blood Glucose, Over The Counter
Updated March 19, 2024. 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.