Data / Medical devices / United States / Mio Labs Inc.
Mio Labs Inc.: FDA-registered device maker in Franklin D Roosevelt, NY, United States, 3 510(k) clearances
Mio Labs Inc. is registered with the FDA (registration 3022418645) in Franklin D Roosevelt, NY, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 28, 2023. 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.
- FDA registration number
- 3022418645
- Address
- KCH, 575 Lexington Ave 14F New York, Franklin D Roosevelt, NY, United States, 10022
- Owner or operator
- Mio Labs Inc. (10084983)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 24, 2023
- Registered through
- 2027
- Brand names listed
- MIO Blood Glucose Monitoring System, model: TeleBGM2282-G, Pylo Blood Glucose Monitoring System, Meter model: GL1-LTE, Test strips model:GL1-STP-50, TeleRPM Blood Glucose Monitoring System, Meter model: TMB-2282-G, Test strips model: TTS01
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter | DQA | 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 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 28, 2023 | K223722 | MIO Blood Glucose Monitoring System | NBW | Substantially Equivalent | Mio Labs, Inc. | accessdata.fda.gov |
| August 29, 2022 | K220676 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| October 18, 2019 | K191430 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Yimi Life-Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of System, Test, Blood Glucose, Over The Counter
Updated June 28, 2023. 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.