Data / Medical devices / United States / Invent Medical Usa, LLC
Invent Medical Usa, LLC: FDA-registered device maker in Warminster, PA, United States, 3 510(k) clearances
Invent Medical Usa, LLC is registered with the FDA (registration 3015259854) in Warminster, PA, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 30, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015259854
- Address
- 1800 Mearns Rd Ste Y, Warminster, PA, United States, 18974
- Owner or operator
- Invent Medical USA, LLC (10059576)
- Roles
- Manufacturer
- First device listed
- February 1, 2019
- Registered through
- 2026
- Brand names listed
- 8sole, AUGO socket, Piro, TALEE PROTECT, Talee, Talee PostOP, Talee, Talee PostOp
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Helmet, Cranial, For Protective Use | NDA | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Corrective Shoe | KNP | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cranial | MVA | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cranial, Laser Scan | OAN | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Thigh Socket, External Component | ISS | 1 | 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 |
|---|---|---|---|---|---|---|
| August 30, 2024 | K241957 | Talee, Talee PostOp | MVA | Substantially Equivalent | Invent Medical USA, LLC | accessdata.fda.gov |
| June 22, 2023 | K230444 | Talee, Talee PostOp | MVA | Substantially Equivalent | Invent Medical USA, LLC | accessdata.fda.gov |
| September 22, 2022 | K220681 | Talee, Talee PostOP | MVA | Substantially Equivalent | Invent Medical USA, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Cranial
- All makers of Orthosis, Cranial, Laser Scan
- All makers of Prosthesis, Thigh Socket, External Component
- All makers of Orthosis, Corrective Shoe
- All makers of Helmet, Cranial, For Protective Use
Updated August 30, 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.