510(k) K203710

Storz Medical MAGNETOLITH Muscle Stimulator by Storz Medical AG — Product Code IPF

K203710 is an FDA 510(k) premarket notification submitted by Storz Medical AG for the device "Storz Medical MAGNETOLITH Muscle Stimulator". The FDA issued a decision of Substantially Equivalent on May 3, 2021. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Storz Medical AG has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2021
Date Received
December 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type