Cleared Traditional

K132855 - HEARTWAY POWER MOBILITY SCOOTER

K132855 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 351-day FDA review.

K132855 · Heartway Medical Products Co., Ltd. · Physical Medicine device
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Aug 2014
Decision
351d
Days
Class 2
Risk

K132855 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, Taiwan, TW). The FDA issued a Cleared decision on August 29, 2014 after a review of 351 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K132855

510(k) Number K132855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2013
Decision Date August 29, 2014
Days to Decision 351 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
236d slower than avg
Panel avg: 115d · This submission: 351d
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 K132855.
HEARTWAY Power Mobility Scooter
K151656 · Heartway Medical Products Co., Ltd. · Nov 2015
HEARTWAY Power Mobility Scooter
K150998 · Heartway Medical Products Co., Ltd. · Sep 2015
HEARTWAY Power Mobility Scooter, BRIO S19
K150987 · Heartway Medical Products Co., Ltd. · Sep 2015
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
K101142 · Heartway Medical Products Co., Ltd. · May 2010
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