K-number	K153224
Device name	VitalStim(R) Plus Electrotherapy System
Applicant	Djo, LLC
Product code	IPF
Device class	Class II
Decision date	Feb 17, 2016
Decision	Substantially Equivalent
Regulation	890.5850

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View the full FDA submission: accessdata.fda.gov

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VitalStim(R) Plus Electrotherapy System

Everything you need for a 510(k) submission. Nothing you don't.