Cleared Traditional

K150548 - Tek RMD (Tek Robotic Mobilization Device)

K150548 is an FDA 510(k) clearance for Tek RMD (Tek Robotic Mobilization Device), manufactured by Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 100-day FDA review.

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.

FDA 510(k) Submission Details - K150548

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 116d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IPL Device Classification - Class 2, Special Controls

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 Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

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.

Regulatory Peers - IPL Wheelchair, Standup

All 49
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HIROLLER ELEVATING WHEELCHAIR
K102837 · Max Mobility, LLC · Dec 2010
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K102734 · Comfort Orthopedic Co., Ltd. · Dec 2010

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.