Cleared Traditional

STONEHEART ROLLER AID (K925247) - FDA 510(k) Clearance

Class I Physical Medicine device.

K925247 · Stoneheart, Inc. · Physical Medicine device
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Feb 1993
Decision
119d
Days
Class 1
Risk

K925247 is an FDA 510(k) clearance for the STONEHEART ROLLER AID. Classified as Chair, With Casters (product code INM), Class I - General Controls.

Submitted by Stoneheart, Inc. (Cheney, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3100 - 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 Stoneheart, Inc. devices

Submission Details

510(k) Number K925247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date February 12, 1993
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INM Chair, With Casters
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3100
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.