ParaMotion

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January 21, 2022 PowerBaseTec GmbH % Juliane Dinter, PhD Consultant (Lead Project Manager) OiP GmbH Struveweg 40 Ludwigsfelde, 14974 Germany Re: K203761 Trade/Device Name: ParaMotion Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: November 25, 2021 Received: December 3, 2021 Dear Dr. Juliane Dinter: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 labeling must be truthful and not misleading. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K203761 Device Name ParaMotion Indications for Use (Describe) - 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 | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92. #### Contact Information | Date of preparation | January 2022 | |---------------------|---------------------------------------------| | Name | PowerBaseTec GmbH | | Address | Göttinger Landstr. 14a 37434 Gieboldehausen | | Contact Person | Niclas Nachtwey<br>General Manager | | E-Mail | info@powerbasetec.de | | Phone | +49(0) 5528 2000660 | #### Application Correspondent (Consultant) | Name | QiP GmbH | |-------------------|--------------------------------------------------------| | Address | Struveweg 40<br>14974 Ludwigsfelde<br>Germany | | Alternate Contact | Dr. rer. medic. Juliane Dinter<br>Lead Project Manager | | E-Mail | j.dinter@qip-qm.com | | Phone | +49 3378 2055 180 | | Fax | +49 3378 2055 182 | ## Subject Device | Trade Name | ParaMotion | | | |---------------------|---------------------|--|--| | Common Name | Standup Wheelchair | | | | Classification Name | Wheelchair, Standup | | | | Regulatory Number | 21 CFR 890.3900 | | | | Product Code | IPL | | | | Device Class | II | | | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a logo for PowerBaseTec, which is abbreviated as PBT. The logo is green and white and features a shield with wings. The wings are spread out on either side of the shield. The letters PBT are in large, bold font in the center of the shield. | Review Panel | Physical Medicine | |---------------------|---------------------| | Predicate Device | | | Trade Name | ParaGolfer | | Common Name | Standup Wheelchair | | Classification Name | Wheelchair, Standup | | Regulatory Number | 890.3900 | | Product Code | IPL | | Device Class | II | | Review Panel | Physical Medicine | | 510(k) number | K060936 | | Clearance | August 07, 2006 | # Subject Device Description The ParaMotion is an all-terrain electric wheelchair with an integrated standing function. All functions are controlled via the joystick control panel. Strong electric motors on the front wheels with wide terrain tires ensure safe handling, and obstacles are overcome easily. The ParaMotion is steered by targeted control of the drive wheels with appropriate operation of the joystick. The dual rear wheel is freely mounted on a steering shaft and thus has a 360° turning radius. This ensures excellent manoeuvrability of the ParaMotion. The joystick control panel also manages the standing function to the driving functions. An electric motor ensures adjustment of the seat from the horizontal position to the upright position. At the same time, the angle of the backrest and the hinges of the leg support are adjusted so that the operator assumes an upright position in the end position. Thanks to the infinitely variable linear motor, any position between the seated position and the standing position can be assumed. All control functions are carried out by means of an R-Net wheelchair control. Thanks to the easy programmability of the R-Net system, the driving functions can be adapted to suit the user's needs. ## 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 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a logo for PowerBaseTec, featuring a stylized design with wings and the letters "PBT" prominently displayed. The wings are spread out above the letters, creating a sense of flight or power. The text "powerBaseTec" is written in a smaller font above the wings. The logo uses a green and white color scheme, giving it a clean and professional look. ## Intended Use Statement The sports wheelchair is designed solely for persons who are unable to walk or have a walking impediment for doing indoor or outdoor sports that require an upright body position. The ParaMotion was specially designed for users who are able to independently move in a sports wheelchair. ## Comparison with Predicate Device The ParaMotion is substantially equivalent to the ParaGolfer Otto Bock HealthCare, cleared on August 07, 2006 as K060936. The ParaMotion is the follow-on device of the ParaGolfer and was designed on the technical basis by the company PowerBaseTec. The ParaMotion has the identically constructed drives, batteries and performance data and is based on the Design of the ParaGolfer. The control technology was replaced by an advanced control technology from Curtis Wright (R-NET). The stand-up unit (seat unit) was developed based on the stand-up unit of the ParaGolfer and optimized in order to improve he usability of the user (for instance an active seat shifting for Decubitus prevention was integrated) and to ensure more efficient repairs by trained technicians. The intended users are identical for both devices (ParaGolfer and ParaMotion). Based on technical, clinical and biological characteristics the ParaMotion is substantially equivalent to the ParaGolfer and may be viewed as follow-up product. The following table provides a comparison of technological characteristics with the predicate device and the reference device to demonstrate substantial equivalence. | Characteristic | Subject Device | Predicate Device<br>K060936 | Justification for<br>Substantial<br>Equivalence | |---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | PowerBaseTec GmbH | Otto Bock | Not applicable | | Model | ParaMotion | ParaGolfer | Not applicable | | Device Classification | | Class II | Identical | | Classification Panel | | 890.3900, IPL | Identical | | Characteristic | Subject Device | Predicate Device<br>K060936 | Justification for<br>Substantial<br>Equivalence | | Regulation Name | Physical Medicine Devices, Physical Medicine<br>Prosthetic Devices Standup Wheelchair | | Identical | | Indications for Use | • Any individual who<br>needs a power<br>wheelchair and can<br>not stand up on<br>their own such as<br>people with<br>paraplegia, spina<br>bifida, cerebral<br>paresis, multiple<br>sclerosis, muscular<br>dystrophy and polio<br>• any individual to<br>take part in sports<br>activities requiring<br>an upright position | • Any individual who<br>needs a power<br>wheelchair and can<br>not stand up on<br>their own such as<br>people with<br>paraplegia, spina<br>bifida, cerebral<br>paresis, multiple<br>sclerosis, muscular<br>dystrophy and polio<br>• any individual to<br>take part in sports<br>activities requiring<br>an upright position | Identical | | Intended Use<br>Statement | The sports wheelchair<br>is designed solely for<br>persons who are<br>unable to walk or have<br>a walking impediment<br>for doing indoor or<br>outdoor sports that<br>require an upright<br>body position. The<br>ParaMotion was<br>specially designed for<br>users who are able to<br>independently move<br>in a sports wheelchair. | The ParaGolfer<br>Standup Wheelchair<br>is a front wheel drive<br>powered standup<br>wheelchair with an<br>air-filled rear wheel<br>for active users.<br>These wheelchairs<br>provide<br>mobility to physically<br>challenged persons.<br>The wheelchair can<br>be moved by the user<br>operating the Curtis<br>Instruments MC-2<br>Control System that is<br>connected to the<br>Micro Motor. The<br>wheelchair is steered<br>by different rotation<br>of the rear wheel. It<br>features a servo-<br>steering with release<br>mechanism. The<br>ParaGolfer has an<br>integrated stand-up | The intended use of the<br>subject and predicate<br>device is similar. | | | | 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. | | | | | | | | Characteristic | Subject Device | Predicate Device<br>K060936 | Justification for<br>Substantial<br>Equivalence | | Patient Population | active handicapped<br>users or disabled<br>people unable to walk | Information not<br>publicly available | Identical | | Intended Users | active handicapped<br>users or people<br>unable to walk | Information not<br>publicly available | Identical | | Frame material | • Base frame- Steel<br>powder Coated<br>• Seat frame- Steel<br>powder Coated and<br>Aluminium Powder<br>Coated<br>• Covering- GRP<br>laminate with<br>gelcoat coating | Information not<br>publicly available | Similar with<br>differences; not<br>clinical relevant due to<br>ISO 10993-series<br>compliance. | | Frame Design/ Style | U frame | Information not<br>publicly available | Identical | | Folding mechanism | No, backrest and<br>footrest for transport | Information not<br>publicly available | Very similar in terms<br>of folding of the<br>backrest and the<br>footrest only for the<br>subject device. Not<br>clinically relevant in<br>terms of safety and<br>performance. | | Seating design | mechanical seat<br>construction with<br>stand-up function | Information not<br>publicly available | Identical | | Seating attachment<br>(integrated, power<br>base, specialty power) | integrated | Information not<br>publicly available | Identical | | Overall Dimensions | - | - | - | | Length (when<br>driving forward):<br>Total length<br>(packing size) | When driving<br>forward:1620mm<br>Total length:1375mm | Information not<br>publicly available | Different but no<br>clinical relevant of<br>critical differences for<br>the user and therefore | | Characteristic | Subject Device | Predicate Device<br>K060936 | Justification for<br>Substantial<br>Equivalence | | Width | 900 mm | Information not<br>publicly available | no adverse impact on<br>safety and<br>effectiveness of the<br>subject device.<br>Identical | | Height | 1010 mm (in sitting<br>position – depending<br>on the position of the<br>backrest) | Information not<br>publicly available | Different. The subject<br>device has a longer<br>total height than the<br>predicate device. A<br>different height is not<br>clinically relevant or<br>has critical differences<br>for the user. The<br>different has therefore<br>no adverse impact on<br>safety and<br>effectiveness of the<br>subject device. | | Seat dimensions | - | - | - | | Seat width | 295 – 465 mm | Information not<br>publicly available | Identical | | Seat depth | 340 – 520 mm | Information not<br>publicly available | Identical with a<br>different range. | | Seat height | 500 – 645 mm | Information not<br>publicly available | The subject device has<br>a smaller seat height<br>than the predicate<br>device. | | Weight | 40,2 kg | Information not<br>available | No comparison<br>possible. Due to<br>similar wheelchair<br>weight this<br>information is not<br>clinically relevant. | | Wheelchair Weight | 212,2 kg | Information not<br>publicly available | Subject device is<br>heavier than the<br>predicate device. Not<br>relevant in terms of<br>intended purpose. | | With batteries | 80 kg | Information not<br>publicly available | Identical | | Without batteries | 132,2 kg | Information not<br>publicly available | Subject device is<br>heavier than the<br>predicate device. Not<br>relevant in terms of<br>intended purpose. | | Controller | 120 Amps | Information not publicly available | The subject device has a smaller controller | | Characteristic | Subject Device | Predicate Device K060936 | Justification for Substantial Equivalence output than the predicate device. | | Drive style (e.g. rear, mid, front) | front | Information not publicly available | Identical | | Motor type | 2 DC Motors pulse width modulation | Information not publicly available…