FDA 510(k)

StimSox(TM) System

K-Number: K151922 · 2016-04-15

Decision Date2016-04-15

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

StimSox(TM) System is the device name listed in this FDA 510(k) record. The listed applicant is Stimmed, LLC. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K151922. 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 StimSox(TM) System?

StimSox(TM) System is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Stimmed, LLC. The 510(k) number is K151922.

When did StimSox(TM) System receive FDA 510(k) clearance?

StimSox(TM) System received FDA 510(k) clearance on 2016-04-15, under 510(k) number K151922.

Who is the listed applicant for StimSox(TM) System?

The FDA 510(k) record lists Stimmed, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StimSox(TM) System?

The FDA product code for StimSox(TM) System is IPF.

Other records listing Stimmed, LLC as applicant

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.

K171071StimSox(TM) System

Related Devices (Code: IPF)

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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.