Cleared Traditional

K950656 - PED ALERT

K950656 is an FDA 510(k) clearance for PED ALERT, manufactured by Orbitec Technologies Corp.. The device is a Class 2 Physical Medicine device with product code IRN cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K950656 · Orbitec Technologies Corp. · Physical Medicine device
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Oct 1995
Decision
254d
Days
Class 2
Risk

K950656 is an FDA 510(k) clearance for the PED ALERT. Classified as Device, Warning, Overload, External Limb, Powered (product code IRN), Class II - Special Controls.

Submitted by Orbitec Technologies Corp. (Madison, US). The FDA issued a Cleared decision on October 25, 1995 after a review of 254 days - an extended review cycle.

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 Orbitec Technologies Corp. devices

FDA 510(k) Submission Details - K950656

510(k) Number K950656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date October 25, 1995
Days to Decision 254 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
139d slower than avg
Panel avg: 115d · This submission: 254d
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.