(315 days)
Not Found
No
The summary describes a mechanical and electrical add-on for wheelchairs with a basic speed-limiting software function, but there is no mention of AI or ML capabilities, training data, or performance metrics typically associated with such technologies.
No.
The device is described as a support for mobility, increasing autonomy, and enabling recreational and sporting activities by adding auxiliary power to a manual wheelchair, rather than providing therapy for a medical condition.
No
The device is an add-on to manual wheelchairs to provide auxiliary power and increase mobility, not to diagnose medical conditions.
No
The device description clearly states it is a "handcycle mechanism that adapts to a manual wheelchair" and includes components like an "electric motor located in the front wheel," "mechanical brakes," and a "transmission." While it mentions software managing a motor brake, the core of the device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "a support to the mobility of active manual wheelchairs' users" and "to add auxiliary power to the manual wheelchair, increasing the mobility for the wheelchair's user." This is a mechanical aid for mobility, not a diagnostic test performed on biological samples.
- Device Description: The description details 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." This is a physical device for propulsion and mobility.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The device is a mobility aid designed to enhance the function of a manual wheelchair.
N/A
Intended Use / Indications for Use
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.
Product codes
ITI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended user is a person with motor disability who needs of the wheelchair support for movement. The device is for indoor and outdoor use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Braking distance:
§ 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).
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)
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4
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, 2025
Batec Mobility S.L.
C/ Illa de Buda 2
08192, Sant Quirze del Vallès, Barcelona
SPAIN |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| 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 Electric
Powered wheelchair
Physical Medicine
21 CFR 890.3860
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)
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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 | EQUIVALENCE
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
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. | KLICK 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
KLICK device.
KLICK 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. | Same |
| Intended Use | Batec devices are medical
devices designed for active,
disabled wheelchair users with
max 110 kg of weight. Batec
devices are designed to add
auxiliary power to the manual
wheelchair, quickly and easily.
The intended user is a person
with motor disability who needs
of the wheelchair's support for
movement. Coupling the Batec
device to the wheelchair raises
the front castors off the ground.
The single wheel of the "traction
unit" is then used for steering.
The resultant 3-wheeler vehicle
increase the mobility of the
patient and allows him to cover
up 50km of travel range both | KLICK devices are medical devices
designed for active, disabled
wheelchair users with max 120 kg
of weight. KLICK devices are
designed to add auxiliary power to
the manual wheelchair, quickly and
easily. The intended user is a person
with motor disability who needs of
the wheelchair's support for
movement. Coupling the KLICK
device to the wheelchair raises the
front castors off the ground. The
single wheel of the "traction unit" is
then used for steering. The resultant
3-wheeler vehicle increase the
mobility of the patient and allows
him to cover up 50km of travel
range both indoor and outdoor. The
system is easy to connect and
disconnect. | Same |
| | SUBJECT DEVICE | PREDICATE | EQUIVALENCE DISCUSSION |
| | is easy to connect and
disconnect.
The first set up is provided by
Batec's trained specialist. | The first set up is provided by
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
suitable for rotation,
acceleration and brake | Front wheel: driven wheel
suitable for rotation,
acceleration and 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
Ø140 mm in Mini 2 and Ø200
mm in Scrambler 2
Automatic electronic brake
limits max speed to ≤ 120% of
set limit | Electronic brake, left and right
mechanical brake | Similar, there are
no
safety or
effectiveness
concerns. |
| Braking distance |