Cleared Traditional

K882974 - FORCE GUARD I

K882974 is an FDA 510(k) clearance for FORCE GUARD I, manufactured by Boulder Impact Monitors, Inc.. The device is a Class 2 Physical Medicine device with product code IRN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K882974 · Boulder Impact Monitors, Inc. · Physical Medicine device
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Nov 1988
Decision
112d
Days
Class 2
Risk

K882974 is an FDA 510(k) clearance for the FORCE GUARD I. Classified as Device, Warning, Overload, External Limb, Powered (product code IRN), Class II - Special Controls.

Submitted by Boulder Impact Monitors, Inc. (Boulder, US). The FDA issued a Cleared decision on November 4, 1988 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5575 - 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 Boulder Impact Monitors, Inc. devices

FDA 510(k) Submission Details - K882974

510(k) Number K882974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1988
Decision Date November 04, 1988
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRN Device Classification - Class 2, Special Controls

Product Code IRN Device, Warning, Overload, External Limb, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5575
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.