Cleared Traditional

K053078 - ERGOSELECT 100 K/P, ERGOSELECT 200 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 116d · 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 Consultant

Tuv America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ISD Exerciser, Measuring

All 26
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K053078.
ActiSpec Activity Monitor
K143512 · Sleep Modus, Inc. · Aug 2015
ERGOSELECT/GE
K112121 · Ergoline GmbH · Oct 2012
ACTITRAINER
K080545 · Actigraph, LLC · Jul 2008
QUINTON MEDTRACK CR PLUS TREADMILL
K990866 · Quinton, Inc. · Apr 1999
REHCOR
K990813 · Electromed Corp. · Apr 1999
ULE-2, MULE-2, HAND ACCESSORY KIT
K962855 · Penny and Giles Biometrics , Ltd. · Dec 1996

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.