510(k) K260142
K260142 is an FDA 510(k) premarket notification submitted by Motion Informatics ltd. for the device "StimelMD (SSMD) system". The FDA issued a decision of Substantially Equivalent on May 27, 2026. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2026
- Date Received
- January 20, 2026
- Clearance Type
- Special
- 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