Cleared Traditional

K983859 - SPECTRUM SMALL FRY

K983859 is an FDA 510(k) clearance for SPECTRUM SMALL FRY, 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 30-day FDA review.

K983859 · Freedom Designs, Inc. · Physical Medicine device
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Nov 1998
Decision
30d
Days
Class 1
Risk

K983859 is an FDA 510(k) clearance for the SPECTRUM SMALL FRY. 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 November 25, 1998 after a review of 30 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 Freedom Designs, Inc. devices

FDA 510(k) Submission Details - K983859

510(k) Number K983859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1998
Decision Date November 25, 1998
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 157
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K983859.
MODEL ACTION AT II MANUAL WHEELCHAIR
K984447 · Invacare Corp. · Jan 1999
MAXXIM
K984493 · Major Mobility Products, Inc. · Jan 1999
DOMINATOR
K983681 · Impact Wheelchair Manufacture, Inc. · Nov 1998
SPECTRUM SPIRIT
K983763 · Freedom Designs, Inc. · Nov 1998
ZIPPIE GS, MODEL # EIZGS
K983639 · Sunrise Medical, Inc. · Oct 1998
MOMENTUM NO. FS008 WHEELCHAIR
K982099 · Sriram Enterprises D.B.A. Momentum Group · Oct 1998