Product code
QDT: Shoe with adjustable sole units
FDA product code · Class I · Physical Medicine
Key facts
| Product code | QDT |
|---|---|
| Device | Shoe with adjustable sole units |
| Device class | Class I |
| Regulation number | 890.3475 |
| Review panel | Physical Medicine |
| Medical specialty | Physical Medicine |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended to adjust the foot’s points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database