Cleared Traditional

Rowheels Revolution 1.0 (K190699) - FDA 510(k) Clearance

Class I Physical Medicine device.

K190699 · Rowheels, Inc. · Physical Medicine device
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May 2019
Decision
52d
Days
Class 1
Risk

K190699 is an FDA 510(k) clearance for the Rowheels Revolution 1.0. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Rowheels, Inc. (Middleton, US). The FDA issued a Cleared decision on May 9, 2019 after a review of 52 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 Rowheels, Inc. devices

Submission Details

510(k) Number K190699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2019
Decision Date May 09, 2019
Days to Decision 52 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

FDA Compliance Group
Kevin Walls

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 456
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