Cleared Traditional

K955295 - SPLASH & GO II

K955295 is an FDA 510(k) clearance for SPLASH & GO II, manufactured by Kid'S Wheel-Chairs. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K955295 · Kid'S Wheel-Chairs · Physical Medicine device
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Nov 1995
Decision
14d
Days
Class 1
Risk

K955295 is an FDA 510(k) clearance for the SPLASH & GO II. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Kid'S Wheel-Chairs (Kenneth City, US). The FDA issued a Cleared decision on November 30, 1995 after a review of 14 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 Kid'S Wheel-Chairs devices

FDA 510(k) Submission Details - K955295

510(k) Number K955295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1995
Decision Date November 30, 1995
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 126
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K955295.
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
SKYWAY
K964682 · Kid'S Wheel-Chairs · Jan 1997
QUICKIE TSR
K952641 · Sunrise Medical, Inc. · Jul 1995
MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS
K951138 · Invacare Corp. · Mar 1995
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293 · O'Tec Corp. · Aug 1994