Product code ITO— Physical Medicine
ORTHOTIC LEG GAIT CORRECTOR DEVICE
- Classification name
- Twister, Brace Setting
- Device class
- Class 1
- Regulation
- 21 CFR 890.3410
- Advisory panel
- Physical Medicine
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code ITO
FDA has cleared device under product code ITO, all in 1980, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code ITO
Recent clearances under product code ITO
Data sourced from openFDA. This site is unofficial and independent of the FDA.