Cleared Traditional

K053078 - ERGOSELECT 100 K/P

K053078 is an FDA 510(k) clearance for ERGOSELECT 100 K/P, manufactured by Ergoline GmbH. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 176-day FDA review.

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

FDA 510(k) Submission Details - K053078

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.

ISD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ISD Exerciser, Measuring

All 17
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