FDA 510(k)

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

Numéro K : K153559 · 2016-08-26

Date de décision2016-08-26

Code produitIMG

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Accelerated Care Plus (Acp). The 510(k) number is K153559.

When did OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System receive FDA 510(k) clearance?

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

Who is the listed applicant for OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System?

The FDA 510(k) record lists Accelerated Care Plus (Acp) as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : IMG)

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Source officielle

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