510(k) K203710
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