Cleared Traditional

K220227 - Auto Folding Scooter, S21F

K220227 is an FDA 510(k) clearance for Auto Folding Scooter, manufactured by Heartway Medical Products Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K220227 · Heartway Medical Products Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
258d
Days
Class 2
Risk

K220227 is an FDA 510(k) clearance for the Auto Folding Scooter, S21F. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Heartway Medical Products Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on October 12, 2022 after a review of 258 days - an extended review cycle.

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: 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 Heartway Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K220227

510(k) Number K220227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2022
Decision Date October 12, 2022
Days to Decision 258 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
143d slower than avg
Panel avg: 115d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

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 Consultant

Roc Chinese-European Industrial Research Society
Ke-Min Jen

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 - INI Vehicle, Motorized 3-wheeled

All 211
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K220227.
eFOLDi Scooter, Lite
K223492 · Suntech UK , Ltd. · Feb 2023
HS186B Scooter
K222711 · Suzhou Master Machinery Manufacturing Co.,Ltd · Jan 2023
Mobility Scooter, Model: W3331F
K222495 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Oct 2022
Electric Scooter
K212090 · Anhui Jbh Medical Apparatus Co., Ltd. · Apr 2022
Mobility Scooter
K220206 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Mar 2022
Mobility Scooter, Model W3468
K220207 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Mar 2022