Product code IMP— Physical Medicine
EDCOOL AND EDCOOL JR. INSTANT COLD PACK
- Classification name
- Cushion, Wheelchair
- Device class
- Class 1
- Regulation
- 21 CFR 890.3920
- Advisory panel
- Physical Medicine
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code IMP
FDA has cleared devices under product code IMP between 1987 and 1989, 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
- 1989
- 1987
Top applicants under product code IMP
Recent clearances under product code IMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.