Cleared Traditional

K182090 - AposTherapy System (FDA 510(k) Clearance)

Class I Physical Medicine device.

K182090 · Apos Medical Assets , Ltd. · Physical Medicine device
Nov 2018
Decision
106d
Days
Class 1
Risk

K182090 is an FDA 510(k) clearance for the AposTherapy System. Classified as Shoe With Adjustable Sole Units (product code QDT), Class I - General Controls.

Submitted by Apos Medical Assets , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on November 16, 2018 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - 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.

Submission Details

510(k) Number K182090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2018
Decision Date November 16, 2018
Days to Decision 106 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 151d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QDT Shoe With Adjustable Sole Units
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
Definition Intended To Adjust The Foot’s Points Of Contact With The Ground To Affect The Distribution Of Weight/force(s) Applied To A Lower Limb
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.