← Product Code [IPL](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPL) · K060936 # PARAGOLFER (K060936) _Parabasetec, GmbH · IPL · Aug 7, 2006 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPL/K060936 ## Device Facts - **Applicant:** Parabasetec, GmbH - **Product Code:** [IPL](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPL.md) - **Decision Date:** Aug 7, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.3900 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use The ParaGoIfer Standup Wheelchair is a front wheel drive powered standup wheelchair with an air-filled rear wheel for active users. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the Curtis Instruments MC-2 Control System that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheel. It features a servo-steering with release mechanism. The ParaGolfer has an integrated stand-up function. When actuating the standup function via the control console, a motorized lifting device moves the seat of the ParaGolfer from a horizontal to vertical position. At the same time the angles on the backrest and footrest adapt in such a way that the user is brought to an upright posture. ## Device Story Front-wheel drive powered standup wheelchair; provides mobility and upright positioning for physically challenged users. User operates Curtis Instruments MC-2 Control System to drive and steer via rear wheel rotation; features servo-steering with release mechanism. Integrated motorized lifting device transitions seat from horizontal to vertical; automatically adjusts backrest and footrest angles to achieve upright posture. Used by active users in various settings; facilitates participation in sports requiring standing. Benefits include independent mobility and ability to achieve upright posture for users with limited lower limb function. ## Clinical Evidence Bench testing only. Device tested by TÜV Product Service per EN 12184, ISO 7176 series (including 7176-20), and ANSI/RESNA WC Vol. 2 Section 21 (EMC). ## Technological Characteristics Front-wheel drive powered standup wheelchair; U-frame construction; Curtis Instruments MC-2 controller; electronic regenerative disc brakes; Micro Motor; air-filled rear wheel; servo-steering mechanism. Tested to EN 12184, ISO 7176, and ANSI/RESNA WC standards. ## Regulatory Identification A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat. ## Predicate Devices - LEVO AG comfort II Wheelchair ([K051387](/device/K051387.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}------------------------------------------------ Image /page/0/Picture/0 description: The image is a black and white logo for "PARAGOLFER by ParaBaseTec". The logo features a circle with the text "PARAGOLFER" at the top and "by ParaBaseTec" at the bottom. Inside the circle is a diamond shape with the letters "PB" stacked on top of each other. There are two wings on either side of the diamond shape. Ko60936 ParaBaseTec GmbH · Hauptstrasse 3 c · 37434 Bodensee 510(k) Summary AUG - 7 2006 ## 510(k) SUMMARY of SAFETY and EFFECTIVENESS # A. General Information | 1. Submitter's Name: | ParaBaseTec, GmbH | |-------------------------|-------------------------------------| | 2. Address: | Haupstrasse 3C
Bodensee, Germany | | 3. Telephone: | 49-5507-979-9108 | | 4. Contact Person: | Anthony Netto | | 5. Date Prepared: | March 28, 2006 | | 6. Registration Number: | In Process | ## B. Device | 1. | Name: | ParaGolfer | |----|----------------------|---------------------| | 2. | Trade Name: | ParaGolfer | | 3. | Common Name: | Standup Wheelchair | | 4. | Classification Name: | Wheelchair, Standup | | 5. | Product Code: | IPL | | 6. | Class: | II | | 7. | Regulation Number: | 890.3900 | ParaBaseTec Inc - Story brick office building - 2 Carlson Parkway, Suite 100 - 3041 - 840 - 3741 E Leland St. Mesa, Az 85215 lek office Ballaing - E - 52 - Toll Free (800) 328-40 58 - Voicemail (800) 905-27 50 lone 1 1 (400) 191 -5-149 63 - Fax1 (763) 519-61 53 · Fax2 (480) 832-01 78 www.parabasetec.com · info@parabasetec.com Bank One 2020 E Mckellips Mesa Az 85213 · Routing nr. 122 100 024 · Account nr. 693 786 899 CEO: Steven Wayne Winter {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a logo with the word "PARAGOLFER" in a circular shape at the top. There is a black diamond shape in the center with the letters "PB" in white. There are two wings on either side of the diamond shape. The words "by paraBaseTec" are at the bottom of the logo. ParaBaseTec GmbH · Hauptstrasse 3 c · 37434 Bodense # C. Identification of Legally Marketed Devices | 1. Name: | comfort II | |------------------|--------------| | 2. K Number: | K051387 | | 3. Date Cleared: | June 10 2005 | ## D. Description of the Device The ParaGolfer Standup Wheelchair is a front wheel drive powered standup wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The ParaGolfer Standup Wheelchair has a "U" frame, controlled by a Curtis Instruments Controller, electronic regenerative disc brakes and Micro Motor. ### E. Intended Use Statement The ParaGoIfer Standup Wheelchair is a front wheel drive powered standup wheelchair with an air-filled rear wheel for active users. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the Curtis Instruments MC-2 Control System that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheel. It features a servo-steering with release mechanism. The ParaGolfer has an integrated stand-up function. When actuating the standup function via the control console, a motorized lifting device moves the seat of the ParaGolfer from a horizontal to vertical position. At the same time the angles on the backrest and footrest adapt in such a way that the user is brought to an upright posture. ## F. Technological Characteristics Summary The ParaGolfer Wheelchair is substantially equivalent to the LEVO AG comfort II Wheelchair, cleared on June 10, 2005 as K051387. Each wheelchair is a standup, powered wheelchair for the active user, with a rigid frame and similar characteristics. ParaBaseTec Inc · Story brick office building · 2 Carlson Parkway, Suite 100 · Plymouth, MN 55447-4407 · 3741 E Leland St. Mesa, Az 85215 Phone + 1 (480) 797-52 59 · Toll Free (800) 328-40 58 · Voicemail (800) 905-27 50 Toll Free Fax (800) 655-49 63 · Fax1 (763) 519-61 53 · Fax2 (480) 832-01 78 www.parabasetec.com · info@parabasetec.com Bank One 2020 E Mckellips Mesa Az 85213 · Routing nr. 122 100 024 · Account nr. 693 786 899 CEO: Steven Wayne Winter {2}------------------------------------------------ #### E. Contact ﻣﻌ ﻣ Contact Person: Anthony Netto Telephone: 49-5507-979-9108 Facsimile: 49-55-7-979-144 #### म् . FDA Registration Registration No.: In Process Owner/Operator No.: In Process #### G. Name/Address of Assembler Assembler Company: OTTO BOCK HealthCare GmbH Street Address: Lindenstrasse 13 City: Konigsee Country: Germany Postal Code: D-07426 #### H. Contact Contact Person: Tom Wessel Telephone: 763-489-5134 Facsimile: 763-519-9017 #### I. FDA Registration Registration Number: 9681725 Owner/Operator Number: 8010097 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a black and white logo for "PARAGOLFER by ParaBaseTec". The logo features a circle with the text "PARAGOLFER" at the top and "by ParaBaseTec" at the bottom. Inside the circle, there is a diamond shape with the letters "PB" stacked on top of each other. There are wing-like shapes extending from the diamond to the left and right. ParaBaseTec GmbH - Hauptstrasse 3 c - 37434 Bodensee The ParaGolfer was tested by TÜV Product Service to the following standards: - EN 12184 . - ISO 7176 Series, including 7176-20 . - ANSI/RESNA WC Vol. 2 Section 21 Amendments 1998 for EMC . with the conclusion that "the test sample fulfills the requirements." ParaBaseTec Inc · Story brick office building · 2 Carlson Parkway, Suite 100 · Plymouth, MN 55447 · 3741 E Leland St. Mesa, A2 85215 Phone + 1 (480) 797-52 59 · Toll Free (800) 328-40 58 · Voicemail (800) 905-27 50 Toll Free Fax (800) 655-49 63 · Fax1 (763) 519-61 53 · Fax2 (480) 832-01 78 www.parabasetec.com · info@parabasetec.com Bank One 2020 E Mckellips Mesa Az 85213 · Routing nr. 122 100 024 · Account nr. 693 786 899 CEO: Steven Wayne Winter {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird design with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 7 2006 ParaBaseTec. GmbH % W F Jackson Associates, Ltd. Mr. William Jackson Regulatory Consultant 2247 Jennifer Lane St. Paul. Minnesota 55109-2851 Re: K060936 Trade/Device Name: ParaGolfer Standup Powered Wheelchair Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: June 30, 2006 Received: July 6, 2006 Dear Mr. Kramer: 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 indications 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, Drug, 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ Page 2 – Mr. William Jackson This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Barbara Baechuo Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use 510(k) Number: To be determined Device Name: ParaGoIfer Standup Powered Wheelchair ## Indications for Use: - Any individual who needs a power wheelchair and can not stand up on their . own such as people with Paraplegia, Spina Bifida, Cerebral Paresis, Multiple Sclerosis, Muscular Dystrophy, and Polio. - Any individual to take part in sports activities requiring an upright position. . PRESCRIPTION USE AND/OR OVER-THE-COUNTER USE X (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) Qurbana Vneenut fa MKM Division of General, Restorative, and Neurological Devices 510(k) Number K060936 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPL/K060936](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPL/K060936) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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