QDT
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Shoe With Adjustable Sole Units
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- FDA 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
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AposTherapy System (K182090) | Apos Medical Assets , Ltd. | 2018-11-16 |
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