Cleared Traditional

K150998 - HEARTWAY Power Mobility Scooter

K150998 is an FDA 510(k) clearance for HEARTWAY Power Mobility 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 167-day FDA review.

K150998 · Heartway Medical Products Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
167d
Days
Class 2
Risk

K150998 is an FDA 510(k) clearance for the HEARTWAY Power Mobility Scooter. 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 September 29, 2015 after a review of 167 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 - K150998

510(k) Number K150998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2015
Decision Date September 29, 2015
Days to Decision 167 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
52d slower than avg
Panel avg: 115d · This submission: 167d
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 Peers - INI Vehicle, Motorized 3-wheeled

All 209
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K150998.
Titan 3W
K160835 · Tzora Active Systems , Ltd. · Feb 2017
ATTO Mobility Scooter
K160909 · Moving Life, Ltd. · Oct 2016
HEARTWAY Power Mobility Scooter
K151656 · Heartway Medical Products Co., Ltd. · Nov 2015
HEARTWAY Power Mobility Scooter, BRIO S19
K150987 · Heartway Medical Products Co., Ltd. · Sep 2015
SupaScoota Motorized vehicle
K143557 · Eurogreen International, Inc. · Sep 2015
Luggie Super
K151944 · Freerider Corporation · Sep 2015