Cleared Traditional

K050507 - SMARTECH, MODEL HOLI I

K050507 is an FDA 510(k) clearance for SMARTECH, manufactured by Cycling and Health Tech. Industry R&D Center. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K050507 · Cycling and Health Tech. Industry R&D Center · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
129d
Days
Class 2
Risk

K050507 is an FDA 510(k) clearance for the SMARTECH, MODEL HOLI I. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Cycling and Health Tech. Industry R&D Center (Taichung, TW). The FDA issued a Cleared decision on July 7, 2005 after a review of 129 days - within the typical 510(k) review window.

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 Cycling and Health Tech. Industry R&D Center devices

FDA 510(k) Submission Details - K050507

510(k) Number K050507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2005
Decision Date July 07, 2005
Days to Decision 129 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
13d slower than avg
Panel avg: 116d · This submission: 129d
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 313
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