Cleared Traditional

K022924 - SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)

K022924 is an FDA 510(k) clearance for SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR), manufactured by Otto Back Healthcare, LP. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K022924 · Otto Back Healthcare, LP · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
43d
Days
Class 1
Risk

K022924 is an FDA 510(k) clearance for the SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Otto Back Healthcare, LP (Minneapolis, US). The FDA issued a Cleared decision on October 17, 2002 after a review of 43 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 Back Healthcare, LP devices

FDA 510(k) Submission Details - K022924

510(k) Number K022924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2002
Decision Date October 17, 2002
Days to Decision 43 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
73d faster than avg
Panel avg: 116d · This submission: 43d
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 333
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K022924.
GIZMO
K023574 · Freedom Designs, Inc. · Dec 2002
TILITE YG AND TILITE YGS
K023606 · Tisport · Nov 2002
AQUILLA MODULAR WHEELCHAIR
K023005 · Haywood Vocational Opportunities · Oct 2002
COMFY HIGH RISER WHEELCHAIR
K022617 · Lenjoy Medical Engineering, Inc. · Sep 2002
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
K022699 · Forever Young Ent. Co., Ltd. · Sep 2002
DELUXE MANUAL WHEELCHAIR HW 4000
K022700 · Forever Young Ent. Co., Ltd. · Sep 2002