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FDA 510(k)

StimSox(TM) System

K-Number: K151922 · 2016-04-15

ApplicantStimmed, LLC
Decision Date2016-04-15
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

StimSox(TM) System is a medical device manufactured by Stimmed, LLC. It received FDA 510(k) clearance on 2016-04-15 under approval 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. It is manufactured by Stimmed, LLC. The 510(k) number is K151922.

When was StimSox(TM) System approved by the FDA?

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

What company makes StimSox(TM) System?

StimSox(TM) System is manufactured by Stimmed, LLC.

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

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

Other Devices by Stimmed, LLC

K171071StimSox(TM) System

Related Devices (Code: IPF)

K160614Xcite Clinical StationRestorative Therapies, Inc. K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. K160992HPM-6000BTL Industries, Inc. K153696Chattanooga Revolution WirelessDjo, LLC K160299geko(TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited K153224VitalStim(R) Plus Electrotherapy SystemDjo, LLC

Official Source

View on FDA Database →

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

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