Product code QDT
- Device name
- Shoe With Adjustable Sole Units
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3475
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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
- Source
- FDA openFDA device classification dataset