Cleared Traditional

K073512 - START JUNIOR

K073512 is an FDA 510(k) clearance for START JUNIOR, 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 31-day FDA review.

K073512 · Otto Bock Healthcare LP · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
31d
Days
Class 1
Risk

K073512 is an FDA 510(k) clearance for the START JUNIOR. 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 January 14, 2008 after a review of 31 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 - K073512

510(k) Number K073512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2007
Decision Date January 14, 2008
Days to Decision 31 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
85d faster than avg
Panel avg: 116d · This submission: 31d
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 K073512.
RTM AND OVAL
K080880 · Next Mobility, LLC · Apr 2008
DANYANG HUAYI K2 AND K7 WHEELCHAIRS
K080207 · Danyang Huayi Medical Supply & Equipment Co, Ltd. · Mar 2008
HUAYI H035 BASIC WHEELCHAIR
K080114 · Danyang Huayi Medical Supply & Equipment Co, Ltd. · Feb 2008
TILITE AERO X
K072311 · Tisport, LLC · Sep 2007
QUICKIE QX MANUAL FOLDING WHEELCHAIR
K072153 · Sunrise Medical, Inc. · Sep 2007
MECHANICAL WHEELCHAIR - L-FRAME SERIES
K071444 · Colours 'N Motion · Jul 2007