Cleared Traditional

K002983 - C.T.M. POWER CHAIR, MODEL HS-5600

K002983 is an FDA 510(k) clearance for C.T.M. POWER CHAIR, manufactured by Warepalmy Enterprise, LLC (Usa). The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K002983 · Warepalmy Enterprise, LLC (Usa) · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
16d
Days
Class 2
Risk

K002983 is an FDA 510(k) clearance for the C.T.M. POWER CHAIR, MODEL HS-5600. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Warepalmy Enterprise, LLC (Usa) (Phoenix, US). The FDA issued a Cleared decision on October 11, 2000 after a review of 16 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 Warepalmy Enterprise, LLC (Usa) devices

FDA 510(k) Submission Details - K002983

510(k) Number K002983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date October 11, 2000
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 316
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K002983.
TEKNIQUE
K010075 · Hoveround Corp. · Feb 2001
TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0
K993406 · Permobil AB · Dec 2000
QUICKIE 2 POWER ASSIST WHEELCHAIR
K001491 · Sunrise Medical, Inc. · Dec 2000
JET 1 POWERED WHEELCHAIR
K001970 · Pride Mobility Products Corp. · Sep 2000
RANGER II M6, MODEL IN-888WNL
K002157 · Invacare Corp. · Aug 2000
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
K001777 · Invacare Corp. · Jul 2000