Cleared Traditional

K940919 - CHIEF SR

K940919 is an FDA 510(k) clearance for CHIEF SR, manufactured by Redman, Inc.. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K940919

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
Combination Product No
PCCP Authorized No
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.

IPL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - IPL Wheelchair, Standup

All 33
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K940919.
LEVO COMPACT LC
K963816 · Levo USA · Oct 1996
SUPERSTAND STAND-UP WHELLCHAIR
K962278 · The Standing Co., Inc. · Oct 1996
CHIEF STANDUP WHEELCHAIR
K940852 · Redman, Inc. · Feb 1995
VERTICALIBRE WHEELCHAIR
K840626 · Poirier S.A. · Feb 1984
RISER STANDUP WHEELCHAIR
K832696 · Imex Medical Systems, Inc. · Sep 1983
LEVO-STAND-UP WHEELCHAIR
K790265 · Marion Laboratories, Inc. · Feb 1979