Cleared Traditional

K152021 - Pure Tilt

K152021 is an FDA 510(k) clearance for Pure Tilt, manufactured by Proactive Comfort, LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K152021 · Proactive Comfort, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
254d
Days
Class 1
Risk

K152021 is an FDA 510(k) clearance for the Pure Tilt. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Proactive Comfort, LLC (Chantilly, US). The FDA issued a Cleared decision on March 31, 2016 after a review of 254 days - an extended review 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: 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.

FDA 510(k) Submission Details - K152021

510(k) Number K152021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2015
Decision Date March 31, 2016
Days to Decision 254 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
138d slower than avg
Panel avg: 116d · This submission: 254d
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 Consultant

Smith Assoicates
EJ Smith

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 398
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K152021.
APEX Manual Wheelchair
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