Cleared Traditional

PED ALERT (K950656) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950656 · Orbitec Technologies Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.