Cleared Traditional

K121561 - FLOW2, SWING

K121561 is an FDA 510(k) clearance for FLOW2, manufactured by Thyssenkrupp Accessibility B.V.. The device is a Class 2 Physical Medicine device with product code ILK cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K121561 · Thyssenkrupp Accessibility B.V. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
150d
Days
Class 2
Risk

K121561 is an FDA 510(k) clearance for the FLOW2, SWING. Classified as Transport, Patient, Powered (product code ILK), Class II - Special Controls.

Submitted by Thyssenkrupp Accessibility B.V. (Zuid-Holland, NL). The FDA issued a Cleared decision on October 26, 2012 after a review of 150 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K121561

510(k) Number K121561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2012
Decision Date October 26, 2012
Days to Decision 150 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
34d slower than avg
Panel avg: 116d · This submission: 150d
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.

Regulatory Peers - ILK Transport, Patient, Powered

All 23
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K121561 · FLOW2, SWING
Download PDF FDA Summary Thyssenkrupp Accessib…