Cleared Traditional

K180880 - DARI Health (FDA 510(k) Clearance)

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

K180880 · Scientific Analytics, Inc. · Physical Medicine device
Mar 2019
Decision
338d
Days
Class 2
Risk

K180880 is an FDA 510(k) clearance for the DARI Health. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Scientific Analytics, Inc. (Lincoln, US). The FDA issued a Cleared decision on March 7, 2019 after a review of 338 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.

Submission Details

510(k) Number K180880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2018
Decision Date March 07, 2019
Days to Decision 338 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 151d · This submission: 338d
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.