Cleared Traditional

K081665 - MILLENIUM II

K081665 is an FDA 510(k) clearance for MILLENIUM II, manufactured by Next Mobility, LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K081665 · Next Mobility, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
14d
Days
Class 1
Risk

K081665 is an FDA 510(k) clearance for the MILLENIUM II. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Next Mobility, LLC (Shelton, US). The FDA issued a Cleared decision on June 27, 2008 after a review of 14 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 - K081665

510(k) Number K081665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2008
Decision Date June 27, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 116d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IOR Wheelchair, Mechanical

All 441
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K081665.
JUMAO MANUAL WHEELCHAIR
K082784 · Danyang Jumao Healthcare Equipment Co., Ltd. · Oct 2008
DIGNITY 100
K082246 · Dignity Medical Devices, Inc. · Sep 2008
HAIDA MODEL HD11 MANUAL WHEELCHAIR
K082274 · Jiangyin East China Medical Technology Co., Ltd. · Aug 2008
MARTIN CHAIR, MODEL C4S1
K080506 · Martin Manufacturing Co., LLC · Jun 2008
MANUAL RIGID MOBILITY WHEELCHAIR
K080270 · Freedom Designs, Inc. · Apr 2008
RTM AND OVAL
K080880 · Next Mobility, LLC · Apr 2008

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K081665 · MILLENIUM II
Download PDF FDA Summary Next Mobility, LLC