Cleared Traditional

K102110 - 24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN

K102110 is an FDA 510(k) clearance for 24 WIDEN WHEELCHAIR (JY/CT-H28), manufactured by Foshan Shunde Jaeyong Hardware Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K102110 · Foshan Shunde Jaeyong Hardware Co., Ltd. · Physical Medicine device
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Oct 2010
Decision
90d
Days
Class 1
Risk

K102110 is an FDA 510(k) clearance for the 24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT W.... Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Foshan Shunde Jaeyong Hardware Co., Ltd. (Greenwood Village, US). The FDA issued a Cleared decision on October 26, 2010 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 - K102110

510(k) Number K102110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2010
Decision Date October 26, 2010
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 116d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 424
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K102110.
ROUGHRIDER
K103212 · Whirlwind Wheelchair International · Jan 2011
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K102061 · Patmont Motor Werks, Inc. · Dec 2010
GALAXY LITE
K102031 · Future Mobility Healthcare, Inc. · Oct 2010
KAIYANG ALUMINUM WHEELCHAIR
K101998 · Guangdong Kaiyang Medical Technology Co., Ltd. · Oct 2010
KAIYANG STEEL WHEELCHAIR
K101999 · Guangdong Kaiyang Medical Technology Co., Ltd. · Oct 2010
K102110 · 24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN
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