FDA product code QDT: Shoe With Adjustable Sole Units
QDT is the FDA product code for shoe with adjustable sole units. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under QDT. The average 510(k) review took 106 days (median 106).
Definition
Intended to adjust the foots points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb
Classification
| Field | Value |
|---|---|
| Device name | Shoe With Adjustable Sole Units |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
510(k) clearances per year for QDT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 106 |
Compare with all 510(k) review times · Search every QDT clearance
Top QDT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apos Medical Assets , Ltd. | 1 | 2018-11-16 |
Most recent QDT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182090 | Apos Medical Assets , Ltd. | AposTherapy System | 2018-11-16 | 106 |
Recalls for QDT devices
openFDA lists no recalls for product code QDT.
Frequently asked questions
What is FDA product code QDT?
QDT is the FDA product code for shoe with adjustable sole units. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is QDT?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QDT?
Across 1 cleared submissions the average was 106 days from receipt to decision (median 106).
Which companies have the most QDT clearances?
Apos Medical Assets , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QDT
- Run a recall and safety report across every QDT manufacturer
- Watch product code QDT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times