Cleared Traditional

K832161 - AMBULIZER MODEL MC-5

K832161 is the FDA 510(k) clearance for AMBULIZER MODEL MC-5 by Mobilizer Medical Products, Inc.. It is a Class 1 Physical Medicine device (product code IOR) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K832161 · Mobilizer Medical Products, Inc. · Physical Medicine device
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Aug 1983
Decision
27d
Days
Class 1
Risk

K832161 is an FDA 510(k) clearance for the AMBULIZER MODEL MC-5. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Mobilizer Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 1, 1983 after a review of 27 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.

View all Mobilizer Medical Products, Inc. devices

Submission Details

510(k) Number K832161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1983
Decision Date August 01, 1983
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 88
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K832161.
PLAIN JANE SERIES WHEELCHAIR
K842232 · Invacare Corp. · Jun 1984
ULTRA-LITE PREMIER
K841830 · Everest & Jennings, Inc. · May 1984
WHEELCHAIR MECHANICAL
K840024 · Amico Lab, Inc. · Jan 1984
ROLLS ROLLITE WHEELCHAIR
K801557 · Invacare Corp. · Jul 1980
PORTABLE WHEELCHAIR & CARRYING CASE
K790183 · Fred Sammons, Inc. · Mar 1979
WHEELCHAIRS, MECHANICAL
K780183 · Orthopedic Equipment Co., Inc. · Feb 1978