Cleared Traditional

K001890 - SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)

K001890 is an FDA 510(k) clearance for SHERPA/KODIAK CUB MOBILITY SYSTEM (MANU..., manufactured by Otto Bock Orthopaedische Industrie, Kg.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K001890 · Otto Bock Orthopaedische Industrie, Kg. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
33d
Days
Class 1
Risk

K001890 is an FDA 510(k) clearance for the SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Otto Bock Orthopaedische Industrie, Kg. (Minneapolis, US). The FDA issued a Cleared decision on July 24, 2000 after a review of 33 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 Otto Bock Orthopaedische Industrie, Kg. devices

FDA 510(k) Submission Details - K001890

510(k) Number K001890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2000
Decision Date July 24, 2000
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
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 221
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K001890.
BREEZY WHEELCHAIR, MODEL 300
K011268 · Sunrise Medical, Inc. · May 2001
MODEL 9000 BARIATRIC WHEELCHAIR
K002317 · Invacare Corp. · Aug 2000
MODEL 9000 PEDIATRIC WHEELCHAIR
K002170 · Invacare Corp. · Aug 2000
ACTION AF-1 WHEELCHAIR
K000174 · Invacare Corp. · Feb 2000
SIGMA MANUAL WHEELCHAIR
K993963 · Sigma Distribution & Supply, Inc. · Jan 2000
MANUAL WHEELCHAIR
K994185 · Major Mobility Products, Inc. · Jan 2000