Cleared Traditional

K082246 - DIGNITY 100

K082246 is an FDA 510(k) clearance for DIGNITY 100, manufactured by Dignity Medical Devices, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K082246 · Dignity Medical Devices, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
32d
Days
Class 1
Risk

K082246 is an FDA 510(k) clearance for the DIGNITY 100. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Dignity Medical Devices, Inc. (Maple Grove, US). The FDA issued a Cleared decision on September 9, 2008 after a review of 32 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.

FDA 510(k) Submission Details - K082246

510(k) Number K082246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2008
Decision Date September 09, 2008
Days to Decision 32 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
84d faster than avg
Panel avg: 116d · This submission: 32d
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 441
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K082246.
HUBANG, MODEL HBL13/HBG12-S
K083044 · Shanghai Hubang Medical Appliances Co., Ltd. · Dec 2008
BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
K082314 · Otto Bock Healthcare LP · Oct 2008
JUMAO MANUAL WHEELCHAIR
K082784 · Danyang Jumao Healthcare Equipment Co., Ltd. · Oct 2008
HAIDA MODEL HD11 MANUAL WHEELCHAIR
K082274 · Jiangyin East China Medical Technology Co., Ltd. · Aug 2008
MILLENIUM II
K081665 · Next Mobility, LLC · Jun 2008
MARTIN CHAIR, MODEL C4S1
K080506 · Martin Manufacturing Co., LLC · Jun 2008
K082246 · DIGNITY 100
Download PDF FDA Summary Dignity Medical Devic…