Cleared Traditional

K940919 - CHIEF SR

K940919 is the FDA 510(k) clearance for CHIEF SR by Redman, Inc.. It is a Class 2 Physical Medicine device (product code IPL) cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K940919 · Redman, Inc. · Physical Medicine device
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Feb 1995
Decision
344d
Days
Class 2
Risk

K940919 is an FDA 510(k) clearance for the CHIEF SR. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Redman, Inc. (Tucson, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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. Elevated predicate reliance profile. 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 Redman, Inc. devices

Submission Details

510(k) Number K940919 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 24, 1994
Decision Date February 03, 1995
Days to Decision 344 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
229d slower than avg
Panel avg: 115d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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.