Cleared Traditional

K052681 - START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)

K052681 is an FDA 510(k) clearance for START FAMILY OF MANUAL WHEELCHAIRS (BASIC, manufactured by Otto Bock Healthcare LP. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K052681 · Otto Bock Healthcare LP · Physical Medicine device
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Oct 2005
Decision
8d
Days
Class 1
Risk

K052681 is an FDA 510(k) clearance for the START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on October 6, 2005 after a review of 8 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 Healthcare LP devices

FDA 510(k) Submission Details - K052681

510(k) Number K052681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2005
Decision Date October 06, 2005
Days to Decision 8 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 116d · This submission: 8d
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 324
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K052681.
MEDLINE PEDIATRIC WHEELCHAIRS
K053574 · Medline Industries, Inc. · Jan 2006
UROK ROCKING WHEELCHAIR, MODEL 700-4XX
K052548 · Amg Medical, Inc. · Jan 2006
A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P
K052586 · Taiwan an I Co., Ltd. · Dec 2005
YK9000 SERIES MANUAL WHEELCHAIR
K052468 · Intco Metal Products (Zhenjiang) Co., Ltd. · Oct 2005
SYRYKER SORANO WHEELCHAIR
K051369 · Stryker Canada · Sep 2005
NISSIN SERIES MECHANICAL WHEELCHAIR
K052521 · Nissin Medical Industries Co., Ltd. · Sep 2005