Cleared Abbreviated

TACAMO MANUAL WHEELCHAIR

K101719 · Dalton Instrument Corp. · Physical Medicine

Aug 2010

Decision

68d

Days

Class 1

Risk

About This 510(k) Submission

K101719 is an FDA 510(k) clearance for the TACAMO MANUAL WHEELCHAIR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Dalton Instrument Corp. (Addiison, US). The FDA issued a Cleared decision on August 25, 2010, 68 days after receiving the submission on June 18, 2010. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K101719 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2010
Decision Date	August 25, 2010
Days to Decision	68 days
Submission Type	Abbreviated
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — General Controls
CFR Regulation	21 CFR 890.3850
Definition	A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.