Cleared Traditional

K954427 - HELPING HAND

K954427 is an FDA 510(k) clearance for HELPING HAND, manufactured by Kinetic Rehabilitation Instruments, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K954427 · Kinetic Rehabilitation Instruments, Inc. · Physical Medicine device
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Sep 1996
Decision
360d
Days
Class 2
Risk

K954427 is an FDA 510(k) clearance for the HELPING HAND. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Kinetic Rehabilitation Instruments, Inc. (Washington, US). The FDA issued a Cleared decision on September 16, 1996 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Kinetic Rehabilitation Instruments, Inc. devices

FDA 510(k) Submission Details - K954427

510(k) Number K954427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1995
Decision Date September 16, 1996
Days to Decision 360 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
245d slower than avg
Panel avg: 115d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 - ITI Wheelchair, Powered

All 376
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K954427.
CHOICE POWERED WHEELCHAIR
K963808 · American Medical Technology, Inc. · Feb 1997
CHIPS STANDUP WHEELCHAIR
K955547 · International Healthcare Solutions, Inc. · Sep 1996
CHIPS POWERED WHEELCHAIR
K955548 · International Healthcare Solutions, Inc. · Sep 1996
SELF PROPELLED ROBOTIC WHEEL (SPRW)
K950025 · Datatran, Inc. · Sep 1996
TK40 - TILTMASTER
K961744 · Mechanical Application Designs, Inc. · Jul 1996
OMEGATRAC BY TEFTEC
K955240 · Teftec Corp. · Jul 1996