Data / Medical devices / United States / Prevounce Health, Inc
Prevounce Health, Inc: FDA-registered device maker in Indianapolis, IN, United States, 6 510(k) clearances
Prevounce Health, Inc is registered with the FDA (registration 3017500903) in Indianapolis, IN, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017500903
- Address
- 3250 N Post Road STE 180, Indianapolis, IN, United States, 46226
- Owner or operator
- Prevounce Health, Inc (10078004)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 23, 2020
- Registered through
- 2026
- Brand names listed
- OX1-LTE Pulse Oximeter, Pylo Blood Glucose Meter Device GL1-LTE, Pylo Health 1775-N Blood Pressure Monitor, Pylo Health 200-LTE Weight Scale, Pylo Health 300-LTE Weight Scale, Pylo Health 802-LTE Blood Pressure Monitor, Pylo Health 900-LTE Blood Pressure Monitor, Pylo Health Control Solution GL1-CTR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Complaint file establishment | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Complaint file establishment | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 28, 2023 | K223722 | MIO Blood Glucose Monitoring System | NBW | Substantially Equivalent | Mio Labs, Inc. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| March 9, 2021 | K202891 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| August 28, 2014 | K140582 | FINGERTIP PULSE OXIMETER | DQA | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| March 1, 2013 | K123780 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| January 31, 2012 | K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics 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
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Oximeter
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
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.