Cleared Traditional

K021617 - C.T.M. POWER CHAIR, MODEL HS-2800

K021617 is an FDA 510(k) clearance for C.T.M. POWER CHAIR, manufactured by C.T.M. Homecare Product, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K021617 · C.T.M. Homecare Product, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
78d
Days
Class 2
Risk

K021617 is an FDA 510(k) clearance for the C.T.M. POWER CHAIR, MODEL HS-2800. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by C.T.M. Homecare Product, Inc. (Phoenix, US). The FDA issued a Cleared decision on August 2, 2002 after a review of 78 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.

View all C.T.M. Homecare Product, Inc. devices

FDA 510(k) Submission Details - K021617

510(k) Number K021617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date August 02, 2002
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 288
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K021617.
WU'S POWERED WHEELCHAIR, MAMBO 5
K030709 · Wu'S Tech Co., Ltd. · Apr 2003
HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS
K022993 · Hoveround Corp. · Dec 2002
STORM TDX POWER WHEELCHAIR
K023589 · Invacare Corp. · Nov 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · Invacare Corp. · Jun 2002
TEKNIQUE-HOVEROUND POWER WHEEL CHAIR
K021136 · Hoveround Corp. · Apr 2002
INVACARE ELEVATING SEAT OPTION ESS6
K013516 · Invacare Corp. · Dec 2001