← FDA Medical Device Classifications
Shoe With Adjustable Sole Units
QDT · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3475
Classification
- FDA Product Code
QDT- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 890.3475
- Review panel
- PM
- Medical specialty
- Physical Medicine
- Submission type
- 4
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
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
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 7
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown