Cleared Traditional

K130848 - SHANGHAI PHOENIX MECHANICAL WHEELCHAIR

K130848 is an FDA 510(k) clearance for SHANGHAI PHOENIX MECHANICAL WHEELCHAIR, manufactured by Shanghai Phoenix Medical Equipment Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K130848 · Shanghai Phoenix Medical Equipment Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
231d
Days
Class 1
Risk

K130848 is an FDA 510(k) clearance for the SHANGHAI PHOENIX MECHANICAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Shanghai Phoenix Medical Equipment Co., Ltd. (Jinshan District, Shanghai, CN). The FDA issued a Cleared decision on November 12, 2013 after a review of 231 days - an extended review cycle.

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 - K130848

510(k) Number K130848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2013
Decision Date November 12, 2013
Days to Decision 231 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
115d slower than avg
Panel avg: 116d · This submission: 231d
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 400
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K130848.
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K130788 · Future Mobility Healthcare, Inc. · Dec 2013
TX WHEELCHAIR CHASSIS
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K131529 · Pingdingshan Shenxing Healthcare Technology Co., L · Sep 2013
QUICKIE & ZIPPIE SERIES
K123975 · Sunrise Medical · Aug 2013
K130848 · SHANGHAI PHOENIX MECHANICAL WHEELCHAIR
Download PDF FDA Summary Shanghai Phoenix Medi…