Cleared Traditional

K153559 - OmniVersa Multi-Modality Therapy System...

K153559 is an FDA 510(k) clearance for OmniVersa Multi-Modality Therapy System..., manufactured by Accelerated Care Plus (Acp). The device is a Class 2 Physical Medicine device with product code IMG cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K153559 · Accelerated Care Plus (Acp) · Physical Medicine device
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Aug 2016
Decision
256d
Days
Class 2
Risk

K153559 is an FDA 510(k) clearance for the OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy.... Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Accelerated Care Plus (Acp) (Reno, US). The FDA issued a Cleared decision on August 26, 2016 after a review of 256 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Accelerated Care Plus (Acp) devices

FDA 510(k) Submission Details - K153559

510(k) Number K153559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2015
Decision Date August 26, 2016
Days to Decision 256 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 115d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMG Device Classification - Class 2, Special Controls

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 37
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K153559.
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