Cleared Traditional

K073701 - DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000

K073701 is an FDA 510(k) clearance for DANE TECHNOLOGIES WHEELCHAIR MOVER, manufactured by Dane Technologies. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K073701 · Dane Technologies · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
28d
Days
Class 2
Risk

K073701 is an FDA 510(k) clearance for the DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Dane Technologies (Brooklyn Park, US). The FDA issued a Cleared decision on January 28, 2008 after a review of 28 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 - K073701

510(k) Number K073701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2007
Decision Date January 28, 2008
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 116d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITI Wheelchair, Powered

All 549
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K073701.
CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR
K080385 · E1 Ent., Inc. · May 2008
TACAHE PC1350 POWER WHEELCHAIR
K080373 · Dalton Medical Corp. · Apr 2008
C.T.M. POWER CHAIR, MODEL HS-1500
K073686 · C.T.M. Homecare Product, Inc. · Feb 2008
A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I
K073134 · Invacare Corporation · Nov 2007
COMFORT POWERED WHEELCHAIR, LY-EB 206
K072711 · Comfort Orthopedic Co., Ltd. · Oct 2007
ZIP'R PC
K072224 · Global Fabtech Wheelchair (Shanghai) Co., Ltd. · Sep 2007

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K073701 · DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000
Download PDF FDA Summary Dane Technologies