Product code MRI— Physical Medicine
ORLAU SWIVEL WALKER
- Classification name
- Orthosis, Truncal/Orthosis, Limb
- Device class
- Class 1
- Regulation
- 21 CFR 890.3490
- Advisory panel
- Physical Medicine
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MRI
FDA has cleared devices under product code MRI between 1996 and 1997, filed by 2 applicant companies. 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.
Clearances per year
- 1997
- 1996
Top applicants under product code MRI
Recent clearances under product code MRI
Data sourced from openFDA. This site is unofficial and independent of the FDA.