Cleared Traditional

K101142 - HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER

K101142 is an FDA 510(k) clearance for HEARTWAY LIGHTWEIGHT 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 34-day FDA review.

K101142 · Heartway Medical Products Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
34d
Days
Class 2
Risk

K101142 is an FDA 510(k) clearance for the HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Heartway Medical Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on May 26, 2010 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heartway Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K101142

510(k) Number K101142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2010
Decision Date May 26, 2010
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 116
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K101142.
HEARTWAY Power Mobility Scooter
K150998 · Heartway Medical Products Co., Ltd. · Sep 2015
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K150987 · Heartway Medical Products Co., Ltd. · Sep 2015
HEARTWAY POWER MOBILITY SCOOTER
K132855 · Heartway Medical Products Co., Ltd. · Aug 2014
HEARTWAY POWER MOBILITY SCOOTER, S11
K101143 · Heartway Medical Products Co., Ltd. · May 2010
HEARTWAY POWER MOBILITY SCOOTER, S12
K092650 · Heartway Medical Products Co., Ltd. · Oct 2009
HEARTWAY POWER MOBILITY SCOOTER, S9
K092154 · Heartway Medical Products Co., Ltd. · Sep 2009