StimelMD (SSMD) system— 510(k) K260142
Substantially EquivalentMotion Informatics ltd.
FDA 510(k) clearance K260142 for StimelMD (SSMD) system, Substantially Equivalent on 2026-05-27. Applicant: Motion Informatics ltd.. Device class: 2.
Summary
Motion Informatics filed the StimelMD (SSMD) system under IPF, powered muscle stimulators. The record doesn't expand "SSMD".
Class II, 21 CFR 890.5850. Physical Medicine is both the classification panel and the review panel, and it came in as a Special 510(k).
Motion Informatics is in Yarka, Israel. The decision came 127 calendar days after receipt (January 20 to May 27, 2026).
Clearance details
- Applicant
- Motion Informatics ltd.
- Product code
- Product code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Yarka, IL
Recent devices under product code IPF
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