Cleared Traditional

K221435 - SUPERTILT PLUS (STP)

K221435 is an FDA 510(k) clearance for SUPERTILT PLUS (STP), manufactured by Power Plus Mobility. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K221435 · Power Plus Mobility · Physical Medicine device
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Oct 2022
Decision
164d
Days
Class 1
Risk

K221435 is an FDA 510(k) clearance for the SUPERTILT PLUS (STP). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Power Plus Mobility (Guelph, CA). The FDA issued a Cleared decision on October 28, 2022 after a review of 164 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.

View all Power Plus Mobility devices

FDA 510(k) Submission Details - K221435

510(k) Number K221435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2022
Decision Date October 28, 2022
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
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 92
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K221435.
Manual Wheelchair (A006)
K231110 · Ningbo Shenyu Medical Equipment Co.,Ltd · Jun 2023
Zhenjiang Assure Mechanical Wheelchair,model:K1
K231320 · Zhenjiang Assure Medical Equipment Co., Ltd. · Jun 2023
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
K220698 · Panthera AB · Feb 2023
Manual Wheelchair
K220671 · Hebei Ruilangde Medical Equipment Technology Group Co., Ltd. · Jul 2022
RoughRider Aurora Manual Wheelchair
K200715 · Roughrider America, LLC · Jun 2022
Aluminum back folding wheelchair SYIV 100-LQXAL2482-407
K213790 · Mobility Source Medical Technology Co., Ltd. · Mar 2022