510(k) K190173

Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound by Jk-Holding GmbH — Product Code LEJ

K190173 is an FDA 510(k) premarket notification submitted by Jk-Holding GmbH for the device "Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound". The FDA issued a decision of Substantially Equivalent on May 10, 2019. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Jk-Holding GmbH has at least 3 other 510(k) clearances on record.