Cleared Traditional

K080373 - TACAHE PC1350 POWER WHEELCHAIR

K080373 is an FDA 510(k) clearance for TACAHE PC1350 POWER WHEELCHAIR, manufactured by Dalton Medical Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K080373 · Dalton Medical Corp. · Physical Medicine device
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Apr 2008
Decision
62d
Days
Class 2
Risk

K080373 is an FDA 510(k) clearance for the TACAHE PC1350 POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Dalton Medical Corp. (Carrollton, US). The FDA issued a Cleared decision on April 14, 2008 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K080373

510(k) Number K080373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2008
Decision Date April 14, 2008
Days to Decision 62 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
54d faster than avg
Panel avg: 116d · This submission: 62d
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 549
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K080373.
K450 POWERED WHEELCHAIR
K081964 · Permobil AB · Jul 2008
FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)
K073330 · Freedom Sciences, LLC · Jun 2008
CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR
K080385 · E1 Ent., Inc. · May 2008
C.T.M. POWER CHAIR, MODEL HS-1500
K073686 · C.T.M. Homecare Product, Inc. · Feb 2008
DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000
K073701 · Dane Technologies · Jan 2008
A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I
K073134 · Invacare Corporation · Nov 2007
K080373 · TACAHE PC1350 POWER WHEELCHAIR
Download PDF Dalton Medical Corp.