Cleared Abbreviated

K101719 - TACAMO MANUAL WHEELCHAIR

K101719 is an FDA 510(k) clearance for TACAMO MANUAL WHEELCHAIR, manufactured by Dalton Instrument Corp.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Abbreviated 510(k) pathway after a 68-day FDA review.

K101719 · Dalton Instrument Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
68d
Days
Class 1
Risk

K101719 is an FDA 510(k) clearance for the TACAMO MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Dalton Instrument Corp. (Addiison, US). The FDA issued a Cleared decision on August 25, 2010 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K101719

510(k) Number K101719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 116d · This submission: 68d
Pathway characteristics
Standards-based clearance path.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 424
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K101719.
GALAXY LITE
K102031 · Future Mobility Healthcare, Inc. · Oct 2010
KAIYANG ALUMINUM WHEELCHAIR
K101998 · Guangdong Kaiyang Medical Technology Co., Ltd. · Oct 2010
KAIYANG STEEL WHEELCHAIR
K101999 · Guangdong Kaiyang Medical Technology Co., Ltd. · Oct 2010
MAC-MOBILE AQUATIC CHAIR
K101217 · Rehamed Intl., LLC · Jun 2010
ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
K101277 · Future Mobility Healthcare, Inc. · Jun 2010
MECHANICAL WHEELCHAIR, MODEL DS 202-S
K100824 · Suzhou KD Medical · May 2010
K101719 · TACAMO MANUAL WHEELCHAIR
Download PDF FDA Summary Dalton Instrument Cor…