Wellell, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / October 28, 2025
K243023WiZARD 520 Full Face MaskMay 23, 2025