Cleared Traditional

K253257 - Virgo Mobility Scooter (Virgo-D

K253257 is an FDA 510(k) clearance for Virgo Mobility Scooter (Virgo-D, manufactured by Jiangsu Intco 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 252-day FDA review.

K253257 · Jiangsu Intco Medical Products Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
252d
Days
Class 2
Risk

K253257 is an FDA 510(k) clearance for the Virgo Mobility Scooter (Virgo-D,Virgo-F). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Jiangsu Intco Medical Products Co., Ltd. (Zhenjiang, CN). The FDA issued a Cleared decision on June 8, 2026 after a review of 252 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 Jiangsu Intco Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K253257

510(k) Number K253257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date June 08, 2026
Days to Decision 252 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 115d · This submission: 252d
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 117
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K253257.
Scooter (YD-03)
K253600 · Yurob Rehabilitation Medical Co., Ltd. · Jun 2026
Mobility Scooter (Air Carbon)
K260717 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · May 2026
Mobility Scooter (X-12, X-14, X-17)
K260237 · Wuyi Aichi Industry and Trade Co., Ltd. · Apr 2026
Electrical Scooter (SM4226)
K252813 · Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. · Mar 2026
Power Mobility Scooter (MJMA01, MJMA02)
K253936 · Nanjing Mijo Technology Co., Ltd. · Mar 2026
Mobility Scooter (CL-Q3, CL-Q4)
K253631 · Zhejiang Wei Ling New Energy Technology Co., Ltd. · Feb 2026