Data / Medical devices / United States / Innovative Health Sciences
Innovative Health Sciences: FDA-registered device maker in Chester, NY, United States, 2 510(k) clearances
Innovative Health Sciences is registered with the FDA (registration 3018229072) in Chester, NY, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018229072
- Address
- 1108 Kings Hwy Suite 4, Chester, NY, United States, 10918
- Owner or operator
- Innovative Health Sciences (10076716)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 9, 2021
- Registered through
- 2026
- Brand names listed
- Insignis SubQ Infusion Set, Insignis Syringe Infusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Immunoglobulin G (Igg) Infusion System | PKP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 1, 2024 | K232328 | Insignis Syringe Infusion System | FPA | Substantially Equivalent | Innovative Health Sciences, LLC | accessdata.fda.gov |
| August 13, 2021 | K202279 | Insignis Subcutaneous Needle Sets | FPA | Substantially Equivalent | Innovative Health Sciences, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion
- All makers of Immunoglobulin G (Igg) Infusion System
- All makers of Set, Administration, Intravascular
Updated March 1, 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.