← Product Code [ISD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISD) · K112121 # ERGOSELECT/GE (K112121) _Ergoline GmbH · ISD · Oct 31, 2012 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISD/K112121 ## Device Facts - **Applicant:** Ergoline GmbH - **Product Code:** [ISD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISD.md) - **Decision Date:** Oct 31, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5360 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity. ## Device Story Ergoselect / GE is a series of ergometer bicycles used for physiotherapy and obesity treatment. The device measures patient performance data during exercise procedures. It supports stand-alone operation or integration with external PC systems for control. Healthcare providers use the output to monitor patient progress and adjust exercise regimens. The device is intended for clinical use to assist in muscle redevelopment and joint motion restoration. ## Clinical Evidence No clinical data provided. Substantial equivalence is supported by bench testing, including compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 14971 (risk management), and ISO 10993 (biocompatibility). ## Technological Characteristics Measuring exercise equipment (ergometer bicycles). Features computer control for stand-alone or PC-integrated operation. Complies with IEC 60601-1, IEC 60601-1-2, ISO 14971, and ISO 10993 standards. ## Regulatory Identification Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation. ## Special Controls *Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. ## Predicate Devices - Ergoselect 100 K/P; Ergoselect 200 K/P ([K053078](/device/K053078.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K112121 ergoline 10/22/2012 OCT 3 1 2012 ### 510(k) Summary >> 510(k) Summary as required by section 807.92(c) Submission Applicant: Ergoline GmbH Lindenstrasse 5 72475 Bitz / Germany Establishment Registration Number: 3005438755 Application Correspondent/Contact: think! Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen · Germany Phone: +49-7462-924 05 I Fax: +49-7462-924 128 E-mail: andrea@thinkworks.biz Common name: Exerciser #### Classification name: Measuring exerciser > 21 CFR - 890.5360 Measuring exercise equipment Product Code: ISD Trade name: Ergoline Ergoselect / GE Predicate Device: K-number: K053078 Device name: Ergoselect 100 K/P; Ergoselect 200 K/P Firm: Ergoline GmbH ### Description of the Device: The Ergoselect is the result of long-standing experience and its consequent implementation. The system is convincing thru the optimal, and therefore, cost-effective configuration of the ergometer according to in medical ergometer specific requirements. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). {1}------------------------------------------------ ## 510(k) Summary Ergoline Ergoselect / GE measures data concerning patients procedures and in conjunction with ergometer bicycles procedures. ergoline Ergoselect / GE ergometer includes following models (P/K versions): Ergoselect 50 Ergoselect 100 / 200 Ergoselect 600 Ergoselect 1000 Ergoselect 1200 Optibike 50 med Optibike med #### Indications for Use: Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity. #### Technological characteristics compared to the Predicate Device: The features of the subject device are substantially equivalent to the predicate device based on similarities in terms of design, operational, configurational, ergometrical, technical and safety characteristics. In addition, the classification and intended use of the predicate and subject device are the same. The Ergoselect / GE ergometer can be deemed substantially equivalent and safe and effective for its indicated use. #### Non-clinical performance data: Ergoline certifies compliance with the requirements among others of following device relevant standards: IEC 60601-1: Medical Electrical Equipment, General Requirements for Safety; IEC 60601-1-2: Medical Electrical Equipment, General Requirements for Safety, Electromagnetic compatibility - requirements and tests; ISO 14971: Medical devices -Application of risk management to medical devices; and ISO 10993 Biological evaluation of medical devices. #### Summary: The presented data that was conducted on the Ergoline / GE ergometer shows in its results and in comparison that the products perform as well as or better than the predicate device, safe and effective for their intended use and do not raise any questions regarding safety and effectiveness. All models that are covered by this 510(k) premarket notification have been on the market in Europe for years with no device failures. The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 31 2012 Ergoline GmbH % Ms. Andrea Pecsi Schwarzwaldstrasse 5 Tuttlingen, BW 78532, Germany Re: K112121 Trade Name: Ergoselect / GE Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring exercise equipment Regulatory Class: Class II Product Code: ISD Dated: October 22, 2012 Received: October 26, 2012 Dear Ms. Pecsi: : We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indivious for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drig, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device loculture to contract wabling If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ ## Page 2 - Ms. Andrea Pecsi forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinny by events ons (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you docure operation as weboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark N. Mikkelsen Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): K112121 Device Name: Ergoline Ergoselect / GE Indications for Use: Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity. Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of_l___________________________________________________________________________________________________________________________________________________________________ (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISD/K112121](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISD/K112121) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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