Cleared Traditional

K850877 - MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR

K850877 is an FDA 510(k) clearance for MONOLIFT MPE2, manufactured by Ketronic, Inc.. The device is a Class 2 Physical Medicine device with product code ILK cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K850877 · Ketronic, Inc. · Physical Medicine device
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Jun 1985
Decision
103d
Days
Class 2
Risk

K850877 is an FDA 510(k) clearance for the MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR. Classified as Transport, Patient, Powered (product code ILK), Class II - Special Controls.

Submitted by Ketronic, Inc. (The Netherlands, NL). The FDA issued a Cleared decision on June 12, 1985 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5150 - 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 Ketronic, Inc. devices

FDA 510(k) Submission Details - K850877

510(k) Number K850877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date June 12, 1985
Days to Decision 103 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILK Device Classification - Class 2, Special Controls

Product Code ILK Transport, Patient, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5150
Definition A Powered Patient Transport Is A Motorized Device Intended For Use In Mitigating Mobility Impairment Caused By Injury Or Other Disease By Moving A Person From One Location Or Level To Another, Such As Up And Down Flights Of Stairs (e.g., Attendant-operated Portable Stair-climbing Chairs). This Generic Type Of Device Does Not Include Motorized Three-wheeled Vehicles Or Wheelchairs.
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.