Product code ISW— Physical Medicine
C-LEG (3C100)
- Classification name
- Assembly, Knee/Shank/Ankle/Foot, External
- Device class
- Class 2
- Regulation
- 21 CFR 890.3500
- Advisory panel
- Physical Medicine
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code ISW
FDA has cleared device under product code ISW, all in 1999, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code ISW
Recent clearances under product code ISW
Data sourced from openFDA. This site is unofficial and independent of the FDA.