Data / Medical devices / United States / Hypertec HCM LLC
Hypertec HCM LLC: FDA-registered device maker in Plainfield, IN, United States, 13 510(k) clearances
Hypertec HCM LLC is registered with the FDA (registration 3013896610) in Plainfield, IN, United States. It lists 19 device types. The FDA files 13 510(k) clearances under its listings, the newest dated October 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013896610
- Address
- 1570 Perry Road, Plainfield, IN, United States, 46168
- Owner or operator
- Hypertec HCM LLC (10053193)
- Roles
- Repackager or relabeler
- First device listed
- November 16, 2016
- Registered through
- 2026
- Brand names listed
- No Proprietary Name
Devices it lists
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 |
|---|---|---|---|---|---|---|
| October 30, 2023 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | MWI | Substantially Equivalent | Empatica S.r.l. | accessdata.fda.gov |
| February 23, 2023 | K213863 | Everion+ System | MSX | Substantially Equivalent | Biofourmis Singapore Pte., Ltd. | accessdata.fda.gov |
| November 20, 2022 | K221282 | Empatica Health Monitoring Platform | DQA | Substantially Equivalent | Empatica S.r.l. | accessdata.fda.gov |
| November 8, 2019 | K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System | NBW | Substantially Equivalent | Ascensia Diabetes Care | accessdata.fda.gov |
| May 10, 2019 | K183319 | Triangle System | DXH | Substantially Equivalent | AliveCor, Inc. | accessdata.fda.gov |
| March 7, 2019 | K183078 | VitalConnect Platform, VitalPatch Biosensor | DRG | Substantially Equivalent | Vitalconnect, Inc. | accessdata.fda.gov |
| October 25, 2018 | K170723 | Swaive Thermometer SWT1A | FLL | Substantially Equivalent | E-Care Technology Co., Ltd. | accessdata.fda.gov |
| June 30, 2015 | K142642 | Vitalograph Model 6600 Compact | BZG | Substantially Equivalent | Vitalograph (Ireland) , Ltd. | accessdata.fda.gov |
| March 26, 2015 | K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System | NBW | Substantially Equivalent | Nipro Diagnostics, Inc. | accessdata.fda.gov |
| October 2, 2014 | K141542 | NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) | DQA | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 11, 2013 | K131021 | PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| June 5, 2008 | K081285 | FINGER PULSE OXIMETER, MODEL 9560 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| March 3, 2005 | K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
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Updated October 30, 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.