Data / Medical devices / Shoe With Adjustable Sole Units
Shoe With Adjustable Sole Units (QDT): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Shoe With Adjustable Sole Units (product code QDT, Class 1, 21 CFR 890.3475). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 16, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QDT
- Device class
- 1
- Regulation
- 890.3475
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 2 |
| Israel | 1 |
| Germany | 1 |
Makers of Shoe With Adjustable Sole Units
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 |
|---|---|---|---|---|---|---|---|---|
| APOS Medical Assets Ltd | Tel Aviv, Israel | Manufacturer | 1 | November 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Billy Footwear | Kent, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Redthera Technology Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fior And Gentz GMBH | Lueneburg Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industech International Inc. | Verona, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Motion Technologies, Inc. | Orlando, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou First Light Industry Co.,ltd | WENZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 16, 2018. 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.