Cleared Traditional

K840624 - COMBI

K840624 is the FDA 510(k) clearance for COMBI by Besam, Inc.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K840624 · Besam, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
13d
Days
Class 2
Risk

K840624 is an FDA 510(k) clearance for the COMBI. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Besam, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 27, 1984 after a review of 13 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.

View all Besam, Inc. devices

Submission Details

510(k) Number K840624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1984
Decision Date February 27, 1984
Days to Decision 13 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 190
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K840624.
RANGER(II)
K852813 · Invacare Corp. · Aug 1985
POWER DRIVE WHEELCHAIR-VARIOUS
K851381 · Everest & Jennings, Inc. · Jul 1985
OMNIDIRECTIONAL POWERED WHEEL CHAIR
K841542 · Kinetic Concepts, Inc. · May 1984
PREMIER
K834552 · Everest & Jennings, Inc. · Jan 1984
SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER
K823175 · Kinetic Concepts, Inc. · Nov 1982