Product code ISY— Physical Medicine
REL-K ARTIFICAL LIMB PROSTHESIS
- Classification name
- Joint, Knee, External Limb Component
- Device class
- Class 1
- Regulation
- 21 CFR 890.3420
- Advisory panel
- Physical Medicine
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code ISY
FDA has cleared device under product code ISY, all in 2010, 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 ISY
Recent clearances under product code ISY
Data sourced from openFDA. This site is unofficial and independent of the FDA.