Cleared Traditional

K191356 - i3 Foldable Mobility Scooter (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191356 · Puc Perfect Union Co., Ltd. · Physical Medicine device
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Jan 2022
Decision
966d
Days
Class 2
Risk

K191356 is an FDA 510(k) clearance for the i3 Foldable Mobility Scooter. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Puc Perfect Union Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on January 11, 2022 after a review of 966 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Puc Perfect Union Co., Ltd. devices

Submission Details

510(k) Number K191356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2019
Decision Date January 11, 2022
Days to Decision 966 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
851d slower than avg
Panel avg: 115d · This submission: 966d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 343
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K191356.
Mobility Scooter (X-12, X-14, X-17)
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Mobility Scooter (CL-Q3, CL-Q4)
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Electric Scooter (DDF100)
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