Cleared Traditional

K240120 - Merlexi Craft Bariatric series of manua...

K240120 is an FDA 510(k) clearance for Merlexi Craft Bariatric series of manua..., manufactured by Turbo Wheelchair Co., Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K240120 · Turbo Wheelchair Co., Inc. · Physical Medicine device
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Jul 2024
Decision
171d
Days
Class 1
Risk

K240120 is an FDA 510(k) clearance for the Merlexi Craft Bariatric series of manual wheelchairs. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Turbo Wheelchair Co., Inc. (Jeffersonville, US). The FDA issued a Cleared decision on July 5, 2024 after a review of 171 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.

View all Turbo Wheelchair Co., Inc. devices

FDA 510(k) Submission Details - K240120

510(k) Number K240120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2024
Decision Date July 05, 2024
Days to Decision 171 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 115d · This submission: 171d
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 92
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K240120.
Manual Wheelchair (MASY23)
K242722 · Sichuan Ast Medical Equipment Co., Ltd. · Nov 2024
Manual Wheelchair (SYIV100-CA9221)
K242560 · Foshan Shunkangda Medical Tech Co., Ltd. · Oct 2024
Manual Wheelchair
K241460 · Lichtmega Technology Co., Ltd. · Jul 2024
YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE
K232230 · Zhenjiang Assure Medical Equipment Co., Ltd. · Oct 2023
Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)
K232198 · Zhenjiang Assure Medical Equipment Co., Ltd. · Sep 2023
Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS
K232199 · Zhenjiang Assure Medical Equipment Co., Ltd. · Sep 2023