Cleared Traditional

ABLE-X (K120783) - FDA 510(k) Clearance

Class I Physical Medicine device.

K120783 · Im-Able, Ltd. · Physical Medicine device
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Jun 2012
Decision
97d
Days
Class 1
Risk

K120783 is an FDA 510(k) clearance for the ABLE-X. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by Im-Able, Ltd. (Palos Verdes Estates, US). The FDA issued a Cleared decision on June 20, 2012 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5370 - 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 Im-Able, Ltd. devices

Submission Details

510(k) Number K120783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2012
Decision Date June 20, 2012
Days to Decision 97 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ION Exerciser, Non-measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5370
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.