Data / Medical devices / Foot Examination Tool For Inflammatory Changes
Foot Examination Tool For Inflammatory Changes (OIZ): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Foot Examination Tool For Inflammatory Changes (product code OIZ, Class 1, 21 CFR 890.5050). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on October 8, 2015, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OIZ
- Device class
- 1
- Regulation
- 890.5050
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Ireland | 1 |
| Lithuania | 1 |
| China | 1 |
| Canada | 1 |
Makers of Foot Examination Tool For Inflammatory Changes
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| BLUEDROP MEDICAL Ltd | Galway Galway(County), Ireland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diabetis JSC | Vilnius Vilniaus Apskritis, Lithuania | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Empo Health, Inc. | San Bruno, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Weifeng Houseware Co. Ltd | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orpyx Medical Technologies Inc. | Calgary Alberta, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OnCore Manufacturing | Westborough, MA, United States | Contract manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Podimetrics, Inc. | Somerville, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richardson Products, Inc. | Frankfort, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siren | San Francisco, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonic Manufacturing Technologies, Inc. | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 8, 2015. 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.