Cleared Traditional

K943129 - ECONOSTAND

K943129 is an FDA 510(k) clearance for ECONOSTAND, manufactured by Sf Research Corp.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K943129 · Sf Research Corp. · Physical Medicine device
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Nov 1994
Decision
141d
Days
Class 2
Risk

K943129 is an FDA 510(k) clearance for the ECONOSTAND. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Sf Research Corp. (Overland Park, US). The FDA issued a Cleared decision on November 17, 1994 after a review of 141 days - within the typical 510(k) review window.

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. 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 Sf Research Corp. devices

FDA 510(k) Submission Details - K943129

510(k) Number K943129 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 29, 1994
Decision Date November 17, 1994
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
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 34
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K943129.
SUPERSTAND STAND-UP WHELLCHAIR
K962278 · The Standing Co., Inc. · Oct 1996
CHIEF STANDUP WHEELCHAIR
K940852 · Redman, Inc. · Feb 1995
CHIEF SR
K940919 · 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