Cleared Traditional

K971389 - ECLIPSE 400 MANUALLY OPERATED WHEELCAIR

K971389 is an FDA 510(k) clearance for ECLIPSE 400 MANUALLY OPERATED WHEELCAIR, manufactured by Pdg Product Design Group, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K971389 · Pdg Product Design Group, Inc. · Physical Medicine device
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May 1997
Decision
25d
Days
Class 1
Risk

K971389 is an FDA 510(k) clearance for the ECLIPSE 400 MANUALLY OPERATED WHEELCAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Pdg Product Design Group, Inc. (Vancouver, Bc, CA). The FDA issued a Cleared decision on May 9, 1997 after a review of 25 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pdg Product Design Group, Inc. devices

FDA 510(k) Submission Details - K971389

510(k) Number K971389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1997
Decision Date May 09, 1997
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
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 125
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K971389.
UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
K973418 · Assembly Required Dist., Inc. · Oct 1997
ASLI
K973473 · Texin Industrial (International) , Ltd. · Sep 1997
TOOL-LESS WHEEL CHAIR
K972797 · Sunrise Medical, Inc. · Aug 1997
ADVENTURER
K971142 · T.E.S., Ltd. · Apr 1997
ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR
K964932 · L & M Resource Information Service, Inc. · Mar 1997
BENTLEY MANUALLY OPERATED WHEELCHAIR
K970311 · Pdg Product Design Group, Inc. · Feb 1997