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FDA 510(k)

StimelMD (SSMD) system

K-Number: K260142 · 2026-05-27

ApplicantMotion Informatics ltd.
Decision Date2026-05-27
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

StimelMD (SSMD) system is the device name listed in this FDA 510(k) record. The listed applicant is Motion Informatics ltd.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K260142. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StimelMD (SSMD) system?

StimelMD (SSMD) system is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Motion Informatics ltd.. The 510(k) number is K260142.

When did StimelMD (SSMD) system receive FDA 510(k) clearance?

StimelMD (SSMD) system received FDA 510(k) clearance on 2026-05-27, under 510(k) number K260142.

Who is the listed applicant for StimelMD (SSMD) system?

The FDA 510(k) record lists Motion Informatics ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StimelMD (SSMD) system?

The FDA product code for StimelMD (SSMD) system is IPF.

Related Devices (Code: IPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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