510(k) K210748

Well-life TM Pen Needles, Well-life TM Safety Pen Needles by W. L. Med Co., Ltd. — Product Code FMI

K210748 is an FDA 510(k) premarket notification submitted by W. L. Med Co., Ltd. for the device "Well-life TM Pen Needles, Well-life TM Safety Pen Needles". The FDA issued a decision of Substantially Equivalent on May 25, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.