Cleared Traditional

K980107 - RUNCH INDUSTRIAL WHEELCHAIR

K980107 is an FDA 510(k) clearance for RUNCH INDUSTRIAL WHEELCHAIR, manufactured by Runch Group USA, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K980107 · Runch Group USA, Inc. · Physical Medicine device
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Feb 1998
Decision
38d
Days
Class 1
Risk

K980107 is an FDA 510(k) clearance for the RUNCH INDUSTRIAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Runch Group USA, Inc. (Houston, US). The FDA issued a Cleared decision on February 19, 1998 after a review of 38 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 Runch Group USA, Inc. devices

FDA 510(k) Submission Details - K980107

510(k) Number K980107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1998
Decision Date February 19, 1998
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
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 138
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K980107.
TC SERIES (WIDE)
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TC SERIES (RECLINER)
K981421 · Get A Life-Give A Living Plus Kids Project, Inc. · Jun 1998
TC SERIES
K981422 · Get A Life-Give A Living Plus Kids Project, Inc. · Jun 1998
BREEZY SERIES
K974820 · Sunrise Medical, Inc. · Jan 1998
ELITE LIGHTWEIGHT WHEELCHAIR
K974197 · Jaken Co., Inc. · Dec 1997
MECHANICAL FOLDING WHEEL CHAIR
K973491 · Heartway Medical Products Co., Ltd. · Dec 1997