Cleared Traditional

K032123 - SHOCKWAVE SUSPENSION WHEELCHAIR

K032123 is an FDA 510(k) clearance for SHOCKWAVE SUSPENSION WHEELCHAIR, manufactured by Per4max Medical, LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K032123 · Per4max Medical, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
21d
Days
Class 1
Risk

K032123 is an FDA 510(k) clearance for the SHOCKWAVE SUSPENSION WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Per4max Medical, LLC (Grand Prairie, US). The FDA issued a Cleared decision on July 31, 2003 after a review of 21 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 Per4max Medical, LLC devices

FDA 510(k) Submission Details - K032123

510(k) Number K032123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2003
Decision Date July 31, 2003
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
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 189
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K032123.
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
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K041072 · Invacare Corporation · May 2004
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K013761 · Medline Industries, Inc. · Dec 2001
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K012370 · Invacare Corp. · Aug 2001
MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR
K012167 · Invacare Corp. · Aug 2001