Cleared Traditional

K923428 - PANDA

K923428 is an FDA 510(k) clearance for PANDA, manufactured by Etac Us, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K923428 · Etac Us, Inc. · Physical Medicine device
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Mar 1993
Decision
234d
Days
Class 1
Risk

K923428 is an FDA 510(k) clearance for the PANDA. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Etac Us, Inc. (Waukesha, US). The FDA issued a Cleared decision on March 4, 1993 after a review of 234 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 Etac Us, Inc. devices

FDA 510(k) Submission Details - K923428

510(k) Number K923428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date March 04, 1993
Days to Decision 234 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
119d slower than avg
Panel avg: 115d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 250
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K923428.
UNIVERSAL WHEELCHAIR
K930411 · Everest & Jennings, Inc. · Mar 1993
PREMIER 2 WHEELCHAIR
K930412 · Everest & Jennings, Inc. · Mar 1993
PREMIER CLASSIC
K930413 · Everest & Jennings, Inc. · Mar 1993
ACTION FX MANUAL WHEELCHAIR
K921847 · Invacare Corp. · May 1992
VOYAGEUR AND LAURENTIAN SERIES WHEELCHAIR
K920391 · Invacare Corp. · Feb 1992
ACTION SERIES MANUAL WHEELCHAIRS, VARIOUS MODELS
K914553 · Invacare Corp. · Oct 1991