Cleared Traditional

K010395 - E-POWER

K010395 is an FDA 510(k) clearance for E-POWER, 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 91-day FDA review.

K010395 · Dalton Medical Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
91d
Days
Class 2
Risk

K010395 is an FDA 510(k) clearance for the E-POWER. 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 May 11, 2001 after a review of 91 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.

FDA 510(k) Submission Details - K010395

510(k) Number K010395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2001
Decision Date May 11, 2001
Days to Decision 91 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 116d · This submission: 91d
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 K010395.
THE NIMBLE ROCKET POWERED WHEELCHAIR
K010941 · Nimble, Inc. · Jun 2001
ALANTE, BATTERY OPERATED POWER WHEELCHAIR
K011153 · Golden Technologies, Inc. · May 2001
POWER TILT AND RECLINE SYSTEM
K010917 · Sunrise Medical, Inc. · May 2001
AMYSEAT TILT/RECLINE SEATING
K011006 · Amysystems · May 2001
REGAL MOTOTRIZED 3 WHEELED VEHICLE
K011227 · Bruno Independent Living Aids, Inc. · May 2001
MP3HD BIG BOY, POWER WHEELCHAIR
K010380 · Merits Health Products., Inc. · May 2001
K010395 · E-POWER
Download PDF FDA Summary Dalton Medical Corp.