Cleared Traditional

K162696 - Kuschall Advance Manual Wheelchair

K162696 is an FDA 510(k) clearance for Kuschall Advance Manual Wheelchair, manufactured by Invacare Corporation. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K162696 · Invacare Corporation · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
92d
Days
Class 1
Risk

K162696 is an FDA 510(k) clearance for the Kuschall Advance Manual Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Invacare Corporation (Elyria, US). The FDA issued a Cleared decision on December 28, 2016 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Invacare Corporation devices

FDA 510(k) Submission Details - K162696

510(k) Number K162696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2016
Decision Date December 28, 2016
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
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 218
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K162696.
GEN_2 and GEN_3 Mechanical Wheelchairs
K170701 · Free Wheelchair Mission · Mar 2017
Kuschall Champion Manual Wheelchair
K162686 · Invacare Corporation · Dec 2016
Kuschall K-Series Attract Manual Wheelchair
K162692 · Invacare Corporation · Dec 2016
APEX Manual Wheelchair
K161425 · Motion Composites · Dec 2016
SUNCO Mechanical Wheelchair, model SKW-9003
K153328 · Danyang Sunco Machinery Co., Ltd. · Jul 2016
Kudu
K151492 · R82 A/S · May 2016