Cleared Traditional

K060926 - TRIPOD

K060926 is an FDA 510(k) clearance for TRIPOD, manufactured by Freedom Designs, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K060926 · Freedom Designs, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
45d
Days
Class 1
Risk

K060926 is an FDA 510(k) clearance for the TRIPOD. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Freedom Designs, Inc. (Simi Valley, US). The FDA issued a Cleared decision on May 19, 2006 after a review of 45 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 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 - K060926

510(k) Number K060926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2006
Decision Date May 19, 2006
Days to Decision 45 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
71d faster than avg
Panel avg: 116d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

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 452
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K060926.
ASTROTILT MANUAL WHEELCHAIR
K061475 · Pdg Product Design Group, Inc. · Jun 2006
FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR
K061010 · Future Mobility Healthcare, Inc. · May 2006
7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L
K061273 · Nova Ortho-Med, Inc. · May 2006
FLIGHT
K061186 · Aero Innovative Research, Inc. · May 2006
INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR
K060582 · Invacare Corporation · Mar 2006
WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100
K060251 · Well Home Health Products Co. · Mar 2006
K060926 · TRIPOD
Download PDF FDA Summary Freedom Designs, Inc.