Cleared Traditional

K053078 - ERGOSELECT 100 K/P, ERGOSELECT 200 K/P (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053078 · Ergoline GmbH · Physical Medicine device
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Apr 2006
Decision
176d
Days
Class 2
Risk

K053078 is an FDA 510(k) clearance for the ERGOSELECT 100 K/P, ERGOSELECT 200 K/P. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Ergoline GmbH (Bitz, B-W, DE). The FDA issued a Cleared decision on April 27, 2006 after a review of 176 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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 Ergoline GmbH devices

Submission Details

510(k) Number K053078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2005
Decision Date April 27, 2006
Days to Decision 176 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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.