Cleared Traditional

K925247 - STONEHEART ROLLER AID

K925247 is an FDA 510(k) clearance for STONEHEART ROLLER AID, manufactured by Stoneheart, Inc.. The device is a Class 1 Physical Medicine device with product code INM cleared through the Traditional 510(k) pathway after a 119-day FDA review.

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

FDA 510(k) Submission Details - K925247

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.

INM Device Classification - Class 1, General Controls

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.

Regulatory Peers - INM Chair, With Casters

All 7
Devices cleared under the same product code (INM) and FDA review panel - the closest regulatory comparables to K925247.
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OB TRIPP TRANSPORT CHAIR
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ROLLCHAIR, ORTHO BUCKET SEAT
K790560 · Maddak, Inc. · Apr 1979