Cleared Traditional

K062646 - RUIKE, MODEL 3411

K062646 is an FDA 510(k) clearance for RUIKE, manufactured by Shanghai Ruike Sports Goods Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K062646 · Shanghai Ruike Sports Goods Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
154d
Days
Class 2
Risk

K062646 is an FDA 510(k) clearance for the RUIKE, MODEL 3411. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Shanghai Ruike Sports Goods Co., Ltd. (Banqiao, TW). The FDA issued a Cleared decision on February 5, 2007 after a review of 154 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.

FDA 510(k) Submission Details - K062646

510(k) Number K062646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2006
Decision Date February 05, 2007
Days to Decision 154 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
38d slower than avg
Panel avg: 116d · This submission: 154d
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 351
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K062645 · Shanghai Ruike Sports Goods Co., Ltd. · Dec 2006
K062646 · RUIKE, MODEL 3411
Download PDF FDA Summary Shanghai Ruike Sports…