Handbike Batec Electric

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION". March 7, 2025 Batec Mobility, S.L. Jordi Clapés Donadeu Quality Manager C/ Illa de Buda 2 Sant Quirze del Vallès, Barcelona 08192 Spain Re: K241159 Trade/Device Name: Handbike Batec Electric Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 4, 2025 Received: March 4, 2025 Dear Jordi Clapés Donadeu: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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). {2}------------------------------------------------ Sincerely, # Tushar Bansal -S for 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K241159 Device Name Handbike Batec Electric #### Indications for Use (Describe) Batec is not intended for specific clinical use, but as a support to the mobility of active manual wheelchairs' users. It is designed to add auxiliary power to the manual wheelchair, increasing the wheelchair's user. Therefore, bearing in mind the operating precautions described in this document, there is no need for professional, technical or aptitude requirements to operate or use a Batec device. Batec devices are intended as add-on devices for wheelchairs, thus the is a person with motor disability who needs of the wheelchair support for movement. | 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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Handbike Batec Electric 510(k) Premarket Notification Submission ## 510(k) Summary | DATE PREPARED:<br>SUBMITTER NAME:<br>SUBMITTER ADDRESS: | March 7, 2025<br>Batec Mobility S.L.<br>C/ Illa de Buda 2<br>08192, Sant Quirze del Vallès, Barcelona<br>SPAIN | |------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | CONTACT:<br>TELEPHONE: | Jordi Clapés<br>+34 93 544 2003 | | e-mail: | jclapes@batec-mobility.com | | DEVICE TRADE NAME:<br>COMMON NAME:<br>REGULATION DESCRIPTION:<br>REGULATION NUMBER:<br>PRODUCT CODE: | Handbike Batec Electric<br>Powered wheelchair<br>Physical Medicine<br>21 CFR 890.3860<br>ITI | | PREDICATE DEVICE(S): | Klick (variants: Power, Race, Monster) (K222502) | ## DEVICE DESCRIPTION: The Handbike Batec Electric is a handcycle mechanism that adapts to a manual wheelchair, forming a three-wheeled chair, allowing the user to move with the help of an electric motor located in the front wheel, optimizing the user's capabilities and increasing their autonomy. Handbike Batec Electric aims to convert a manual wheelchair into an electrically propelled tricycle that allows the disabled collective to make larger and more complex movements and routes that can be made only with the manual wheelchair, increasing their independence and autonomy in daily life by performing recreational and sporting activities. The operation of the Handbike Batec Electric is the same in all models, changing only the wheel size, maximum speed, and equipment. First the handbike must be coupled to the wheelchair. Once the two parts are attached, we will have a set consisting of three wheelchair seat, the transmission and traction on the front wheel. To operate the handbike, the transmission of the handbike must be operated by pedaling with the controls or by pressing the accelerator. In this way we will drive the front wheel with the manufactured product. The device has two independent mechanical brakes (right and a parking brake. In addition. there is an automatic speed-limiting motor brake managed by software, which prevents exceeding 120% of the speed limit setting in each mode. ## SUMMARY OF COMPARISON WITH PREDICATE DEVICE: In the establishment of substantial equivalence, Handibike Batec Electric are compared with the following previously cleared devices: - K222502 Klick (variants: Power, Race, Monster) {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Batec Mobility. The logo features a stylized letter "B" with red wings attached to the left side. To the right of the "B" is the text "BATEC" in bold, black letters. Below "BATEC" is the word "MOBILITY" in a smaller font size. Handbike Batec Electric 510(k) Premarket Notification Submission ## 510(k) Summary Comparison of the proposed devices with the predicate devices is summarized in the following table: | | SUBJECT DEVICE | PREDICATE | EQUIVALENCE<br>DISCUSSION | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| | 510(k) | K241159 | K222502 | - | | Product Code | ITI | ITI | Same | | Class | Class II | Class II | Same | | Regulation Number | 21 CFR 890.3860 | 21 CFR 890.3860 | Same | | Device | Handbike Batec electric | Handbike klaxon Klick | Equivalent | | Indication for Use | Batec is not intended for specific<br>clinical use, but as a support to<br>the mobility of active manual<br>wheelchairs' users. It is<br>designed to add auxiliary power<br>to the manual wheelchair,<br>increasing the mobility for the<br>wheelchair's user. Therefore,<br>bearing in mind the operating<br>precautions described in this<br>document, there is no need for<br>professional, technical or<br>aptitude requirements to operate<br>or use a Batec device.<br>Batec devices are intended as<br>add-on devices for wheelchairs,<br>thus the intended user is a<br>person with motor disability<br>who needs of the wheelchair<br>support for movement. | KLICK is not intended for specific<br>clinical use, but as a support to the<br>mobility of active manual<br>wheelchairs' users. It is designed to<br>add auxiliary power to the manual<br>wheelchair, increasing the mobility<br>for the wheelchair's user. Therefore,<br>bearing in mind the operating<br>precautions described in this<br>document, there is no need for<br>professional, technical or aptitude<br>requirements to operate or use a<br>KLICK device.<br>KLICK devices are intended as add-<br>on devices for wheelchairs, thus the<br>intended user is a person with motor<br>disability who needs of the<br>wheelchair support for movement. | Same | | Intended Use | Batec devices are medical<br>devices designed for active,<br>disabled wheelchair users with<br>max 110 kg of weight. Batec<br>devices are designed to add<br>auxiliary power to the manual<br>wheelchair, quickly and easily.<br>The intended user is a person<br>with motor disability who needs<br>of the wheelchair's support for<br>movement. Coupling the Batec<br>device to the wheelchair raises<br>the front castors off the ground.<br>The single wheel of the "traction<br>unit" is then used for steering.<br>The resultant 3-wheeler vehicle<br>increase the mobility of the<br>patient and allows him to cover<br>up 50km of travel range both | KLICK devices are medical devices<br>designed for active, disabled<br>wheelchair users with max 120 kg<br>of weight. KLICK devices are<br>designed to add auxiliary power to<br>the manual wheelchair, quickly and<br>easily. The intended user is a person<br>with motor disability who needs of<br>the wheelchair's support for<br>movement. Coupling the KLICK<br>device to the wheelchair raises the<br>front castors off the ground. The<br>single wheel of the "traction unit" is<br>then used for steering. The resultant<br>3-wheeler vehicle increase the<br>mobility of the patient and allows<br>him to cover up 50km of travel<br>range both indoor and outdoor. The<br>system is easy to connect and<br>disconnect. | Same | | | SUBJECT DEVICE | PREDICATE | EQUIVALENCE DISCUSSION | | | is easy to connect and<br>disconnect.<br>The first set up is provided by<br>Batec's trained specialist. | The first set up is provided by<br>Klaxon's trained specialist. | | | Use condition | Indoor and outdoor. | Indoor and outdoor. | Same | | Number of wheels | 1 | 1 | Same | | Function of wheels | Front wheel: driven wheel<br>suitable for rotation,<br>acceleration and brake | Front wheel: driven wheel<br>suitable for rotation,<br>acceleration and brake. | Same | | Movement control<br>method | Electronic and mechanic system | Electronic and mechanic system | Same | | Driving System | Direct drive, steering bar,<br>handlebar and twist throttle | Direct drive, steering bar, handlebar<br>and twist throttle | Same | | Display | LCD display | LCD display | Same | | Brake system | Two mechanical brake levers,<br>two callipers, one disc brake<br>Ø140 mm in Mini 2 and Ø200<br>mm in Scrambler 2<br>Automatic electronic brake<br>limits max speed to ≤ 120% of<br>set limit | Electronic brake, left and right<br>mechanical brake | Similar, there are<br>no<br>safety or<br>effectiveness<br>concerns. | | Braking distance | < 1.5 meters at 15 km/h in dry<br>conditions | Not publicly available | Similarly, no safety<br>or effectiveness<br>concerns. | | Maximum Safe<br>operational incline<br>degree | 10° | 6°/ 10% | Similar | | Battery charger | Mini 2: 36 V<br>Scrambler 2: 48 V | 48 V | Same | | Main frame material | Aluminium 7005-T6<br>Aluminium 6061-T6 | Aluminium | Similar, no safety<br>or effectiveness<br>concerns raised. | | Seat cushion | No | No | Same | | Overall Dimension<br>(length*width*height) | Mini 2: W=570 ,H=856, L=870<br>Scrambler 2: L=1070, W=580,<br>H=1020 | Power: W 50 cm x H 90 cm x D 40<br>cm<br>Monster: W 50 cm x H 90 cm x D<br>50 cm | Similar | | Folded Dimension<br>(length*width*height) | Mini 2: W=369, H=719, L=736<br>Scrambler 2: W=310, H=825,<br>L=925 | Not publicly available | n/a | | Front wheel size/type | Mini 2: 12" Aluminium rim,<br>12.5 x 2.75" Tyre<br>Scrambler 2: 19" Aluminium<br>rim, 20 x 2.5" Tyre | Aluminium rim, 14" diameter for<br>Power and race, 20" for Monster | Similar, no safety<br>or effectiveness<br>concerns raised. | | Analysis Rear wheel<br>size/type | No | No | Same | | Max forward speed | 15km/h | 15km/h | Same | | Max reverse speed | 5 km/h | Not publicly available | n/a | | Max loading weight | 110 kg | 120 kg | Similar | | | SUBJECT DEVICE | PREDICATE | EQUIVALENCE<br>DISCUSSION | | Battery | Li-ion battery: 36 V 280 Wh, 36<br>V 576 Wh, 48 V 748 Wh | 3 versions of Lithium-Ion battery<br>48V: 2.9 Ah (140Wh), 5.8 Ah<br>(280Wh), 11.6 Ah (528Wh), | Similar | | Maximum distance of<br>travel on the fully<br>charged battery | Mini 2: 21.5 km using 280 Wh<br>battery<br>44 km using 576 Wh battery<br>Scrambler 2: 57.5 km using 748<br>Wh battery | 45-50 km | Similar | | Motor | Mini 2: Brushless motor<br>nominal 350 W, peak 600 W<br>Scrambler 2: Brushless motor<br>nominal 1440 W, peak 1620 W | is a brushless unit with 250W<br>nominal power for Power variant<br>and 1000W power for the Race and<br>Monster variants | Similar, no safety<br>or effectiveness<br>concerns raised. | | Electronic controller | 20 A nominal rate – 30 A max<br>rate | Not publicly available | n/a | | Turning Radius | 1.2 meters | Not publicly available | n/a | | Maximum obstacle<br>climbing | Climbing forwards without a<br>run-up 50 mm<br>Climbing forwards with a run-up<br>of 500 mm 75 mm<br>Climbing rearwards without a<br>run-up 25 mm<br>Climbing rearwards with a run-<br>up of 500 mm 25 mm<br>Descending forwards 100 mm<br>Descending rearwards 100 mm | To go over steps higher than 50 mm,<br>both uphill and downhill. | Similar | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Batec Mobility. The logo features a stylized letter "O" with red wings attached to the left side. To the right of the "O" is the word "BATEC" in bold, black letters. Below "BATEC" is the word "MOBILITY" in smaller, black letters. # 510(k) Summary {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Batec Mobility. The logo features a stylized red wing design to the left of the word "BATEC" in bold, black letters. Below "BATEC" is the word "MOBILITY" in a smaller, sans-serif font, also in black. The overall design conveys a sense of movement and innovation. ## 510(k) Summary None of the differences presented above impact the substantial equivalence of the subject device when compared to the predicate devices. ## INTENDED USE: As established in the Indications for Use Statement: Batec is not intended for specific clinical use, but as a support to the mobility of active manual wheelchairs' users. It is designed to add auxiliary power to the manual wheelchair, increasing the mobility for the wheelchair's user. Therefore, bearing in mind the operating precautions described in this document, there is no need for professional, technical or aptitude requirements to operate or use a Batec device. Batec devices are intended as add-on devices for wheelchairs, thus the intended user is a person with motor disability who needs of the wheelchair support for movement. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Batec Mobility. The logo features a stylized wing in red and black on the left side. To the right of the wing is the company name, "BATEC," in bold, black letters. Below "BATEC" is the word "MOBILITY" in a smaller, black font. Handbike Batec Electric 510(k) Premarket Notification Submission ## 510(k) Summary #### SUMMARY DISCUSSION OF NON-CLINICAL DATA: The subject device has been tested to determine conformance specifications and requirements taking account of its intended use as a mobility device. Non-clinical testing performed as specified in the following standards and in foreseeable operating conditions showed correct performance of the device as per its intended use: • ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2014, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:2014, ISO 7176-21:2009 (Wheelchairs), IEC 60601-1-2:2014 + A1:2020 and IEC 62133-2 Edition 1.0 2017-02 (Lithium batteries) ## SUMMARY DISCUSSION OF CLINICAL DATA: Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted. #### CONCLUSIONS We believe the intended use, the indications for use and principle of operation Handbike Batec Electric are the same as the intended use, indications for use and performance of the predicate devices. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect safety and effectiveness (SE). - . General information of both devices is the same - Intended use and indications/principle of operations of both devices are the same. ● - There are minimum differences in the technological characteristic/performance data of the ● proposed device and those of the predicate devices, all of them comply with ISO 7176 Wheelchairs. Thus, the SE is not affected. Based on the information provided in this premarket notification, Batec Mobility S.L. concludes that Handbike Batec Electric devices are substantially equivalent to the predicate device with regard to safety and effectiveness.