Cleared Traditional

K120501 - CHAMP CHAMP TRANSIT

K120501 is an FDA 510(k) clearance for CHAMP CHAMP TRANSIT, manufactured by Convaid Products, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K120501 · Convaid Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
212d
Days
Class 1
Risk

K120501 is an FDA 510(k) clearance for the CHAMP CHAMP TRANSIT. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Convaid Products, Inc. (Torrance, US). The FDA issued a Cleared decision on September 20, 2012 after a review of 212 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Convaid Products, Inc. devices

FDA 510(k) Submission Details - K120501

510(k) Number K120501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2012
Decision Date September 20, 2012
Days to Decision 212 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
97d slower than avg
Panel avg: 115d · This submission: 212d
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 253
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K120501.
DISCOVERY TMAX MANUAL WHEELCHAIR
K113164 · Otto Bock Healthcare LP · Mar 2013
MR4500 WHEELCHAIR
K120391 · Wardray Premise, Ltd. · Dec 2012
HELIO
K120628 · Motion Composites · Dec 2012
COMED K-SERIES MANUAL WHEELCHAIR
K120077 · Danyang Comed Healthcare Co., Ltd. · May 2012
GEN_2 MECHANICAL WHEELCHAIR
K113713 · Free Wheelchair Mission · May 2012
ZHENJIANG ASURE MECHANICAL WHEELCHAIR
K112816 · Zhenjiang Assure Medical Equipment Co., Ltd. · Apr 2012