Cleared Traditional

K150548 - Tek RMD (Tek Robotic Mobilization Device) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150548 · Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S · Physical Medicine device
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Jun 2015
Decision
100d
Days
Class 2
Risk

K150548 is an FDA 510(k) clearance for the Tek RMD (Tek Robotic Mobilization Device). Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S (Istanbul, TR). The FDA issued a Cleared decision on June 11, 2015 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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 Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S devices

Submission Details

510(k) Number K150548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2015
Decision Date June 11, 2015
Days to Decision 100 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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 - IPL Wheelchair, Standup

All 65
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K150548.
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