Name: Predicase
Price: 199 USD

K-number	K153559
Device name	OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
Applicant	Accelerated Care Plus (Acp)
Product code	IMG
Device class	Class II
Decision date	Aug 26, 2016
Decision	Substantially Equivalent
Regulation	890.5860

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Source

View the full FDA submission: accessdata.fda.gov

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OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System

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