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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification for the "Handbike Batec Electric." It seeks to establish substantial equivalence to a legally marketed predicate device, "Klick (Product Code ITI)."

The provided document describes a physical medical device (a powered add-on for manual wheelchairs), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested criteria related to AI/SaMD performance studies (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this submission.

The acceptance criteria and proof of meeting those criteria for this non-SaMD device primarily rely on compliance with established performance standards and comparison to a predicate device.

Here's an analysis of the provided information based on the typical requirements for a physical medical device 510(k) submission:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a formal "acceptance criteria" table in the way one might see for an SaMD with performance metrics like sensitivity, specificity, or AUC. Instead, it demonstrates compliance through non-clinical testing against recognized standards and a detailed comparison table with the predicate device. The "reported device performance" is implied by its adherence to these standards and the equivalence shown in the comparative table.

Here's a summary derived from the "SUMMARY OF COMPARISON WITH PREDICATE DEVICE" table and "SUMMARY DISCUSSION OF NON-CLINICAL DATA":

Criterion/Feature (Implicit Acceptance Criteria: Equivalence to Predicate, Compliance with Standards)	Handbike Batec Electric (Subject Device) Performance/Specification	Klick (Predicate Device) Performance/Specification	Equivalence Discussion (Meets Acceptance)
Regulatory Information
510(k) Number	K241159	K222502	-
Product Code	ITI	ITI	Same
Class	Class II	Class II	Same
Regulation Number	21 CFR 890.3860	21 CFR 890.3860	Same
Intended Use/Indications
Device Name	Handbike Batec electric	Handbike klaxon Klick	Equivalent
Indication for Use	Support mobility of active manual wheelchair users; adds auxiliary power. Not for specific clinical use; no professional/technical requirements needed to operate. Intended for persons with motor disability needing wheelchair support.	Same wording.	Same
Intended Use	Medical device for active, disabled wheelchair users (max 110 kg), adds auxiliary power. Intended user: person with motor disability needing wheelchair support. Raises front castors; single front wheel for steering. Improves mobility, allows for larger routes. First setup by Batec's trained specialist.	Similar wording, max 120 kg weight. First setup by Klaxon's trained specialist.	Same (slight difference in max user weight, but deemed equivalent).
Use condition	Indoor and outdoor.	Indoor and outdoor.	Same
Technical Specifications
Number of wheels	1	1	Same
Function of wheels	Front wheel: driven, suitable for rotation, acceleration, brake.	Front wheel: driven, suitable for rotation, acceleration, brake.	Same
Movement control method	Electronic and mechanic system	Electronic and mechanic system	Same
Driving System	Direct drive, steering bar, handlebar and twist throttle	Direct drive, steering bar, handlebar and twist throttle	Same
Display	LCD display	LCD display	Same
Brake system	Two mechanical brake levers, two callipers, one disc brake (Ø140mm/Ø200mm). Automatic electronic brake limits max speed to ≤ 120% of set limit.	Electronic brake, left and right mechanical brake.	Similar, no safety or effectiveness concerns.
Braking distance	< 1.5 meters at 15 km/h in dry conditions	Not publicly available	Similarly, no safety or effectiveness concerns.
Maximum Safe operational incline degree	10°	6°/ 10%	Similar (deemed equivalent).
Battery charger	Mini 2: 36 V; Scrambler 2: 48 V	48 V	Similar (coinciding where applicable).
Main frame material	Aluminium 7005-T6, Aluminium 6061-T6	Aluminium	Similar, no safety or effectiveness concerns raised.
Seat cushion	No	No	Same
Overall Dimension	Mini 2: W=570, H=856, L=870; Scrambler 2: L=1070 W=580, H=1020	Power: W 50cm x H 90cm x D 40cm; Monster: W 50cm x H 90cm x D 50cm	Similar (variations based on models, but overall concept equivalent).
Folded Dimension	Mini 2: W=369, H=719, L=736; Scrambler 2: W=310, H=825, L=925	Not publicly available	n/a
Front wheel size/type	Mini 2: 12" Aluminium rim, 12.5 x 2.75" Tyre; Scrambler 2: 19" Aluminium rim, 20 x 2.5" Tyre	Aluminium rim, 14" diameter for Power and race, 20" for Monster	Similar, no safety or effectiveness concerns raised.
Analysis Rear wheel 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 (within acceptable range for typical use).
Battery	Li-ion battery: 36 V 280 Wh, 36 V 576 Wh, 48 V 748 Wh	3 versions of Lithium-Ion battery 48V: 2.9 Ah (140Wh), 5.8 Ah (280Wh), 11.6 Ah (528Wh)	Similar
Maximum distance of travel on the fully charged battery	Mini 2: 21.5 km (280 Wh), 44 km (576 Wh); Scrambler 2: 57.5 km (748 Wh)	45-50 km	Similar
Motor	Mini 2: Brushless, nominal 350 W, peak 600 W; Scrambler 2: Brushless, nominal 1440 W, peak 1620 W	Brushless, 250W nominal (Power), 1000W (Race/Monster)	Similar, no safety or effectiveness concerns raised.
Electronic controller	20 A nominal – 30 A max	Not publicly available	n/a
Turning Radius	1.2 meters	Not publicly available	n/a
Maximum obstacle climbing	Numerous specific measurements (e.g., 50mm without run-up, 75mm with run-up for climbing forwards)	"To go over steps higher than 50 mm, both uphill and downhill."	Similar (conceptually equivalent performance).
Non-clinical Testing Compliance	Conforms to listed ISO/IEC standards (See point 6)	(Implied predicate also conforms to relevant standards)	Demonstrates safety and performance equivalent to predicate and standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of this 510(k) submission, as it relates to the evaluation of a physical device against performance standards and comparison to a predicate, not to a data-driven or AI/SaMD evaluation. The tests performed are engineering/bench tests on the device itself, not on a dataset of patient information. No patient data or clinical data is mentioned for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable here. "Ground truth" in the context of medical devices like this typically refers to validation against established physical properties, engineering specifications, and safety standards, not interpretation by medical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are relevant for subjective medical image interpretation or clinical outcomes, not for objective physical device testing against engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are for evaluating diagnostic performance of AI or imaging technologies with human readers, which is not the nature of this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device, not an algorithm. However, the document does state that non-clinical testing was performed to demonstrate conformance to specifications and requirements. This is equivalent to "standalone" testing for a physical device.

The document lists the following standards for non-clinical testing:

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 (Medical electrical equipment)
IEC 62133-2 Edition 1.0 2017-02 (Lithium batteries)

These tests are the "study" that proves the device meets the (implicit) acceptance criteria of safety and performance as defined by these consensus standards and substantial equivalence to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, "ground truth" is defined by:

Engineering specifications and design requirements: The device's components and measurements are designed to meet certain performance metrics.
International Consensus Standards (ISO/IEC): These standards define acceptable performance, safety, and durability criteria for wheelchairs and their components.
Comparison to Predicate Device: The predicate device, having already been cleared by the FDA, serves as a benchmark for acceptable safety and effectiveness.

8. The sample size for the training set

This is not applicable. This refers to machine learning algorithms, which are not part of this device.

9. How the ground truth for the training set was established

This is not applicable. This refers to machine learning algorithms, which are not part of this device.

In summary:

The "study" proving the Handbike Batec Electric meets its acceptance criteria is a series of non-clinical bench and engineering tests performed according to recognized international consensus standards (listed in point 6), and a direct comparison of its design, intended use, and technical specifications to a previously cleared predicate device. The acceptance criteria are implicitly defined by compliance with these standards and demonstrated substantial equivalence to the predicate, ensuring its safety and effectiveness for its intended use. No clinical data or human-in-the-loop performance studies were deemed necessary for this 510(k) submission.

Summary

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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"

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(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).

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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

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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)

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Image /page/4/Picture/0 description: The image shows the logo for Batec Mobility. The logo features a stylized letter "O" with red wing-like shapes inside the left side of the "O". To the right of the "O" is the word "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

DATE PREPARED:SUBMITTER NAME:SUBMITTER ADDRESS:	March 7, 2025Batec Mobility S.L.C/ Illa de Buda 208192, Sant Quirze del Vallès, BarcelonaSPAIN
CONTACT:TELEPHONE:	Jordi Clapés+34 93 544 2003
e-mail:	jclapes@batec-mobility.com
DEVICE TRADE NAME:COMMON NAME:REGULATION DESCRIPTION:REGULATION NUMBER:PRODUCT CODE:	Handbike Batec ElectricPowered wheelchairPhysical Medicine21 CFR 890.3860ITI
PREDICATE DEVICE(S):	Klick (variants: Power, Race, Monster) (K222502)

DEVICE DESCRIPTION:

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)

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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	EQUIVALENCEDISCUSSION
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 specificclinical use, but as a support tothe mobility of active manualwheelchairs' users. It isdesigned to add auxiliary powerto the manual wheelchair,increasing the mobility for thewheelchair's user. Therefore,bearing in mind the operatingprecautions described in thisdocument, there is no need forprofessional, technical oraptitude requirements to operateor use a Batec device.Batec devices are intended asadd-on devices for wheelchairs,thus the intended user is aperson with motor disabilitywho needs of the wheelchairsupport for movement.	KLICK is not intended for specificclinical use, but as a support to themobility of active manualwheelchairs' users. It is designed toadd auxiliary power to the manualwheelchair, increasing the mobilityfor the wheelchair's user. Therefore,bearing in mind the operatingprecautions described in thisdocument, there is no need forprofessional, technical or aptituderequirements to operate or use aKLICK device.KLICK devices are intended as add-on devices for wheelchairs, thus theintended user is a person with motordisability who needs of thewheelchair support for movement.	Same
Intended Use	Batec devices are medicaldevices designed for active,disabled wheelchair users withmax 110 kg of weight. Batecdevices are designed to addauxiliary power to the manualwheelchair, quickly and easily.The intended user is a personwith motor disability who needsof the wheelchair's support formovement. Coupling the Batecdevice to the wheelchair raisesthe front castors off the ground.The single wheel of the "tractionunit" is then used for steering.The resultant 3-wheeler vehicleincrease the mobility of thepatient and allows him to coverup 50km of travel range both	KLICK devices are medical devicesdesigned for active, disabledwheelchair users with max 120 kgof weight. KLICK devices aredesigned to add auxiliary power tothe manual wheelchair, quickly andeasily. The intended user is a personwith motor disability who needs ofthe wheelchair's support formovement. Coupling the KLICKdevice to the wheelchair raises thefront castors off the ground. Thesingle wheel of the "traction unit" isthen used for steering. The resultant3-wheeler vehicle increase themobility of the patient and allowshim to cover up 50km of travelrange both indoor and outdoor. Thesystem is easy to connect anddisconnect.	Same
	SUBJECT DEVICE	PREDICATE	EQUIVALENCE DISCUSSION
	is easy to connect anddisconnect.The first set up is provided byBatec's trained specialist.	The first set up is provided byKlaxon's trained specialist.
Use condition	Indoor and outdoor.	Indoor and outdoor.	Same
Number of wheels	1	1	Same
Function of wheels	Front wheel: driven wheelsuitable for rotation,acceleration and brake	Front wheel: driven wheelsuitable for rotation,acceleration and brake.	Same
Movement controlmethod	Electronic and mechanic system	Electronic and mechanic system	Same
Driving System	Direct drive, steering bar,handlebar and twist throttle	Direct drive, steering bar, handlebarand twist throttle	Same
Display	LCD display	LCD display	Same
Brake system	Two mechanical brake levers,two callipers, one disc brakeØ140 mm in Mini 2 and Ø200mm in Scrambler 2Automatic electronic brakelimits max speed to ≤ 120% ofset limit	Electronic brake, left and rightmechanical brake	Similar, there arenosafety oreffectivenessconcerns.
Braking distance	< 1.5 meters at 15 km/h in dryconditions	Not publicly available	Similarly, no safetyor effectivenessconcerns.
Maximum Safeoperational inclinedegree	10°	6°/ 10%	Similar
Battery charger	Mini 2: 36 VScrambler 2: 48 V	48 V	Same
Main frame material	Aluminium 7005-T6Aluminium 6061-T6	Aluminium	Similar, no safetyor effectivenessconcerns raised.
Seat cushion	No	No	Same
Overall Dimension(lengthwidthheight)	Mini 2: W=570 ,H=856, L=870Scrambler 2: L=1070, W=580,H=1020	Power: W 50 cm x H 90 cm x D 40cmMonster: W 50 cm x H 90 cm x D50 cm	Similar
Folded Dimension(lengthwidthheight)	Mini 2: W=369, H=719, L=736Scrambler 2: W=310, H=825,L=925	Not publicly available	n/a
Front wheel size/type	Mini 2: 12" Aluminium rim,12.5 x 2.75" TyreScrambler 2: 19" Aluminiumrim, 20 x 2.5" Tyre	Aluminium rim, 14" diameter forPower and race, 20" for Monster	Similar, no safetyor effectivenessconcerns raised.
Analysis Rear wheelsize/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	EQUIVALENCEDISCUSSION
Battery	Li-ion battery: 36 V 280 Wh, 36V 576 Wh, 48 V 748 Wh	3 versions of Lithium-Ion battery48V: 2.9 Ah (140Wh), 5.8 Ah(280Wh), 11.6 Ah (528Wh),	Similar
Maximum distance oftravel on the fullycharged battery	Mini 2: 21.5 km using 280 Whbattery44 km using 576 Wh batteryScrambler 2: 57.5 km using 748Wh battery	45-50 km	Similar
Motor	Mini 2: Brushless motornominal 350 W, peak 600 WScrambler 2: Brushless motornominal 1440 W, peak 1620 W	is a brushless unit with 250Wnominal power for Power variantand 1000W power for the Race andMonster variants	Similar, no safetyor effectivenessconcerns raised.
Electronic controller	20 A nominal rate – 30 A maxrate	Not publicly available	n/a
Turning Radius	1.2 meters	Not publicly available	n/a
Maximum obstacleclimbing	Climbing forwards without arun-up 50 mmClimbing forwards with a run-upof 500 mm 75 mmClimbing rearwards without arun-up 25 mmClimbing rearwards with a run-up of 500 mm 25 mmDescending forwards 100 mmDescending rearwards 100 mm	To go over steps higher than 50 mm,both uphill and downhill.	Similar

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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

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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 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.

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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.

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).