Cleared Traditional

K872488 - ELASTO-GEL CAST & SPLINT PADS

K872488 is an FDA 510(k) clearance for ELASTO-GEL CAST & SPLINT PADS, manufactured by Southwest Technologies, Inc.. The device is a Class 1 Physical Medicine device with product code IPM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K872488 · Southwest Technologies, Inc. · Physical Medicine device
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Sep 1987
Decision
90d
Days
Class 1
Risk

K872488 is an FDA 510(k) clearance for the ELASTO-GEL CAST & SPLINT PADS. Classified as Cover, Limb (product code IPM), Class I - General Controls.

Submitted by Southwest Technologies, Inc. (Kansas City, US). The FDA issued a Cleared decision on September 21, 1987 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3025 - 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 Southwest Technologies, Inc. devices

FDA 510(k) Submission Details - K872488

510(k) Number K872488 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 23, 1987
Decision Date September 21, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

IPM Device Classification - Class 1, General Controls

Product Code IPM Cover, Limb
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3025
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.