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FDA 510(k)

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

K-Number: K153559 · 2016-08-26

ApplicantAccelerated Care Plus (Acp)
Decision Date2016-08-26
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System is a medical device manufactured by Accelerated Care Plus (Acp). It received FDA 510(k) clearance on 2016-08-26 under approval number K153559. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System?

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System is a medical device that received FDA 510(k) clearance on 2016-08-26. It is manufactured by Accelerated Care Plus (Acp). The 510(k) number is K153559.

When was OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System approved by the FDA?

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System received FDA 510(k) clearance on 2016-08-26, under approval number K153559.

What company makes OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System?

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System is manufactured by Accelerated Care Plus (Acp).

What is the FDA product code for OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System?

The FDA product code for OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System is IMG.

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Related PubMed Literature

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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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