Cleared Traditional

K952431 - SPECTRUM

K952431 is an FDA 510(k) clearance for SPECTRUM, 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 29-day FDA review.

K952431 · Freedom Designs, Inc. · Physical Medicine device
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Jun 1995
Decision
29d
Days
Class 1
Risk

K952431 is an FDA 510(k) clearance for the SPECTRUM. 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 June 22, 1995 after a review of 29 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 - K952431

510(k) Number K952431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1995
Decision Date June 22, 1995
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 116d · This submission: 29d
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 K952431.
QUICKIE TSR
K952641 · Sunrise Medical, Inc. · Jul 1995
J & S WHEELCHAIRS MODELS 500, 500B, 502, 503, 504 AND 500T
K951621 · J&S Associates · Jun 1995
MECHANICAL WHEELCHAIR
K952069 · Grand Seating King Corp. · Jun 1995
MECHANICAL WHEELCHAIR- AVENGER
K945148 · Colours 'N Motion · May 1995
MECHANICAL WHEELCHAIR- CHALLENGER
K945149 · Colours 'N Motion · May 1995
MECHANICAL WHEERCHAIR- ECLIPSE
K945150 · Colours 'N Motion · May 1995
K952431 · SPECTRUM
Download PDF Freedom Designs, Inc.