Cleared Traditional

K131660 - SMART (SMART-D, SMART-DX) (FDA 510(k) Clearance)

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

K131660 · Bts S.P.A. · Physical Medicine device
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Apr 2014
Decision
315d
Days
Class 2
Risk

K131660 is an FDA 510(k) clearance for the SMART (SMART-D, SMART-DX). Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Bts S.P.A. (Padova, IT). The FDA issued a Cleared decision on April 17, 2014 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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. Elevated predicate reliance profile. 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 Bts S.P.A. devices

Submission Details

510(k) Number K131660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2013
Decision Date April 17, 2014
Days to Decision 315 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
200d slower than avg
Panel avg: 115d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXJ Interactive Rehabilitation Exercise Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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.