Cleared Special

K170701 - GEN_2 and GEN_3 Mechanical Wheelchairs

K170701 is an FDA 510(k) clearance for GEN_2 and GEN_3 Mechanical Wheelchairs, manufactured by Free Wheelchair Mission. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Special 510(k) pathway after a 16-day FDA review.

K170701 · Free Wheelchair Mission · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
16d
Days
Class 1
Risk

K170701 is an FDA 510(k) clearance for the GEN_2 and GEN_3 Mechanical Wheelchairs. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Free Wheelchair Mission (Irvine, US). The FDA issued a Cleared decision on March 24, 2017 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K170701

510(k) Number K170701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2017
Decision Date March 24, 2017
Days to Decision 16 days
Submission Type Special
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
100d faster than avg
Panel avg: 116d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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

Sharon Rockwell, Consultant
Sharon Rockwell

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 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K170701.
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K170701 · GEN_2 and GEN_3 Mechanical Wheelchairs
Download PDF FDA Summary Free Wheelchair Missi…