QDT — Shoe With Adjustable Sole Units Class I
FDA product code QDT covers "Shoe With Adjustable Sole Units", a Class I medical device regulated under 21 CFR 890.3475. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QDT
- Device Class
- Class I
- Regulation Number
- 890.3475
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K182090 | apos medical assets | AposTherapy System | November 16, 2018 |