Cleared Traditional

K052534 - TACAHE

K052534 is an FDA 510(k) clearance for TACAHE, 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 134-day FDA review.

K052534 · Dalton Medical Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
134d
Days
Class 2
Risk

K052534 is an FDA 510(k) clearance for the TACAHE. 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 January 27, 2006 after a review of 134 days - within the typical 510(k) review window.

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. 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 Dalton Medical Corp. devices

FDA 510(k) Submission Details - K052534

510(k) Number K052534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2005
Decision Date January 27, 2006
Days to Decision 134 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 115d · This submission: 134d
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 312
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K052534.
WU'S POWERED WHEELCHAIR, MAMBO 36
K070655 · Wu'S Tech Co., Ltd. · Apr 2007
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT
K070489 · Heartway Medical Products Co., Ltd. · Mar 2007
QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR
K062701 · Sunrise Medical, Inc. · Sep 2006
A-200 POWERED WHEELCHAIR
K052706 · Otto Bock Healthcare LP · Dec 2005
WU'S POWERED WHEELCHAIR, MAMBO 2
K052559 · Wu'S Tech Co., Ltd. · Sep 2005
Z-CHAIR
K052353 · Pride Mobility Products Corp. · Sep 2005