Cleared Traditional

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

Class I Physical Medicine device.

K182090 · Apos Medical Assets , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Apos Medical Assets , Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · 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.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT00457132 Completed Interventional

The Effect of Neuromuscular Training on Osteoarthritis: A Comparative Prospective Randomized Study

Dynamic Wedging: A Novel Treatment for Knee Osteoarthritis

60
Patients (est.)
1
Site
Treatment
Purpose
Double blind
Masking
Condition studied Knee Osteoarthritis
Study design Parallel
Eligibility All sexes · 45 Years+
Principal investigator Nahum Halperin, MD
Sponsor Assaf-Harofeh Medical Center
Started 2005-09-01 → Completed 2006-02-01
Primary outcome
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Secondary outcome
SF-36 health survey
Study completed - no results published. This trial concluded in 2006 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov