(345 days)
The TWIST and TWIST R are add-on drive accessories for wheelchairs.
The TWIST and TWIST R devices are intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users.
TWIST and TWIST R devices are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.
The TWIST and TWIST R are add-on drive accessories for wheelchairs. The main parts of the drive unit include a drive wheel with a brushless motor and tire, an Electronic Control Unit (ECU), a removable lithium ion battery pack, an On/Off button and indicators, a carrying and release handle, a battery charger, front and rear lights, and locking pins. The controller includes a wireless interface, On/Off button, battery level LEDs, speed selection lever and brake button, integrated Li-ION battery cell, and a USB-C socket. The handlebar unit includes a wireless interface, On/Off button, battery level LEDs, accelerator, brake levers, integrated Li-ION battery cell, and a USB-C socket.
The provided text focuses on the K240267 510(k) Summary for the Klaxon TWIST and TWIST R add-on drive accessories for wheelchairs. While it details numerous technical specifications and non-clinical testing standards, it does not include acceptance criteria, performance data against those criteria, or information about a study that proves the device meets specific performance targets in the way typically required for AI/ML medical devices.
Instead, the document asserts substantial equivalence to a predicate device (SMOOV O10) based on similar indications for use, intended use, and demonstration of safety and performance through adherence to recognized standards.
Therefore, I cannot populate the table or answer most of the questions using only the provided text as it pertains to AI/ML device performance and acceptance criteria. The device described is a physical powered wheelchair accessory, not an AI/ML diagnostic or prognostic tool.
Here's a breakdown of what can be extracted and why other parts cannot be answered:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document in the context of acceptance criteria and performance results for an AI/ML device. The document lists numerous technical specifications for the device (e.g., max speed, motor power, battery capacity, weight), and declares compliance with various ISO and other standards (listed in section 4). However, it does not provide specific acceptance criteria (e.g., "The device must achieve an accuracy of X% for Y task") nor reported performance against such criteria for an AI/ML algorithm.
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/not provided as the device is a physical powered wheelchair accessory, not an AI/ML device that requires a test set of data for algorithm performance evaluation. The "testing" referred to is non-clinical, related to physical and electrical safety and performance standards of the hardware.
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 information is not applicable/not provided for the same reason as point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided for the same reason as point 2.
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 information is not applicable/not provided as the device is not an AI-assisted diagnostic or prognostic tool used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided for the same reason as point 2 and 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/not provided for the same reason as point 2. The "ground truth" for this type of device would be mechanical, electrical, and safety standards verified through engineering tests.
8. The sample size for the training set:
This information is not applicable/not provided as the device is a physical product and does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
This information is not applicable/not provided for the same reason as point 8.
{0}------------------------------------------------
January 10, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it, representing the Department of Health & Human Services-USA. To the right, there is a blue square with "FDA" in white, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
KLAXON Mobility GmbH Riccardo Colomba Ouality Industriestrasse,1 Arnoldstein, 9601 Austria
Re: K240267
Trade/Device Name: Klaxon (Twist); Klaxon (Twist R) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 3, 2024 Received: December 3, 2024
Dear Riccardo Colomba:
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
Submission Number (if known)
K240267
Device Name
KLAXON (TWIST); KLAXON (TWIST R)
Indications for Use (Describe)
The TWIST and TWIST R are add-on drive accessories for wheelchairs.
The TWIST and TWIST R devices are intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users.
TWIST and TWIST R devices are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(K) SUMMARY
510(K) SUMMARY (21 CFR 807.92 A) 1
1.1 SUBMITTER'S DATA
| Name: | Klaxon-Mobility GmbH |
|---|---|
| Address: | Industriestrasse, 1 ZIP 9601, Arnoldstein Austria |
| Telephone Nr: | +43 (0)6644681294 |
| Contact Person: | Mr Riccardo Colomba (r.colomba@klaxon-klick.com); 0043(0)6763213105 |
| Issue date: | 2023, November, the 20th |
1.2 SUBJECT DEVICE'S DATA
| 510(k) Number: | K240267 |
|---|---|
| Name: | TWIST (main device); TWIST R(variation included in the 510(k)) |
| Classification regulation: | Powered Wheelchairs |
| Regulatory Class: | Class II 21 CFR 890.3860 |
| Classification Panel: | Physical Medicine |
| Product code: | ITI |
1.3 PREDICATE DEVICE'S DATA
Klaxon claims substantial equivalence for the subject device TWIST (in the variations TWIST R) to the predicate device SMOOV O10 by Alber GmbH.
The equivalence is based on same intended use, where technical differences are not affecting the safety.
| 510(k) Number: | K192016 |
|---|---|
| Trade/Device Name: | SMOOV O10 |
| Regulation Number: | 21 CFR 890.3860 |
| Regulation Name: | Powered Wheelchair |
| Regulatory Class: | Class II |
| Product Code: | ITI |
| Classification Panel: | Physical Medicine |
| Dated: | May 19th, 2020 |
| Received: | July 29th, 2019 |
{5}------------------------------------------------
Image /page/5/Picture/2 description: The image is a logo for Klaxon. The logo is a shield shape with a stylized letter "K" inside. The word "KLAXON" is written below the "K" in a smaller font. The logo is black and white.
SUBJECT DEVICE DESCRIPTION 2
INDICATIONS FOR USE 2.1
The TWIST and TWIST R are add-on drive accessories for wheelchairs.
The TWIST and TWIST R devices are intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users.
TWIST and TWIST R devices are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.
2.2 INTENDED USE
The TWIST and TWIST R are medical devices for active wheelchair users with a user weight of 120 kgs and who are reliant on a wheelchair as a result of their disability. The TWIST R are add-on drive for wheelchairs that are attached to a manual wheelchair, converting it into an electrically driven wheelchair and thus significantly increasing the wheelchair user's mobility and flexibility.
The TWIST and TWIST R must always be used, transported, maintained and serviced carefully to keep their performance, efficiency and safety. The TWIST R must only be attached to and operated with wheelchairs that are selected by the specialist dealer or by Klaxon itself.
2.3 VARIATIONS
TWIST is available in two (2) variations (TWIST and TWIST R).
The main difference between TWIST R is given by the number of possible configurations. The TWIST has five (5) possible configurations (following table, points 1 to 5)
The TWIST R has two (2) possible configurations (following table, points 6 and 7). It is basically a simplified system available for the rear installation only.
The configurations could be considered as variations themselves, it is not possible to assign to the single configuration a Commercial name, because each product variation (TWIST R) can be sold with all the components to be used in all the available configurations.
| Variation | Commercialname | Power(W) | Maxspeed(km/h -mph) | Combination | Notes |
|---|---|---|---|---|---|
| 1 | TWIST | 250 | 6 – 3.7 | Front mountedwithout handlebar,user | The system is connected with the frontcentral connector, the castor wheels arelifted off the ground.The controller position is reachable by thewheelchair's occupant. |
| 2 | TWIST | 250 | 6 - 3.7 | Front mountedwithout handlebar,attendant | The system is connected with the frontcentral connector, the castor wheels arelifted off the ground.The controller position is reachable by theoccupant's attendant. |
{6}------------------------------------------------
Image /page/6/Picture/2 description: The image shows a simple line drawing. There is a horizontal line that extends across the majority of the image. A vertical line intersects the horizontal line on the right side of the image, forming a T shape.
Image /page/6/Picture/3 description: The image is a logo for Klaxon. The logo features a stylized letter "K" inside of a hexagon. The letter "K" is bold and black, and the word "KLAXON" is written in smaller letters below the "K".
Klaxon TWIST and TWIST R K240267
| 3 | TWIST | 250 | 6 (10 optional) –3.7 (6.2 optional) | Rear mounted, user | The system is connected with the rearconnector, the castor wheels are on theground.The controller position is reachable by thewheelchair's occupant. |
|---|---|---|---|---|---|
| 4 | TWIST | 250 | 6 – 3.7 | Rear mounted,attendant | The system is connected with the rearconnector, the castor wheels are on theground.The controller position is reachable by theoccupant's attendant. |
| 5 | TWIST | 250 | 10 – 6.2 | Front mounted withhandlebar | The system is connected with the frontcentral connector, the castor wheels arelifted off the ground.The handlebar is mounted. |
| 6 | TWIST R | 250 | 6 (10 optional)3.7 (6.2 optional) | Rear mounted, user | The system is connected with the rearconnector, the castor wheels are on theground.The controller position is reachable by thewheelchair's occupant. |
| 7 | TWIST R | 250 | 6 – 3.7 | Rear mounted,attendant | The system is connected with the rearconnector, the castor wheels are on theground.The controller position is reachable by theoccupant's attendant. |
{7}------------------------------------------------
Klaxon TWIST and TWIST R K240267
Image /page/7/Picture/3 description: The image is a logo for Klaxon. The logo is a stylized letter K inside of a shield-like shape. The word "KLAXON" is written in smaller letters below the K. The logo is black and white.
2.4 TECHNICAL DESCRIPTION
Materials used on the main components
| Description | Material |
|---|---|
| ECU | Various, ECU is RoHS compliant |
| Battery 36V, 4Ah | Various, battery's materials RoHS compliant |
| Handlebar | Aluminium alloy Al6061 |
| Handle grips | polyvinyl chloride (PVC) |
| Hub frame | Aluminium alloy Al6082 and Al7075 |
| Hub motor complete with wheel | Various, motor's materials RoHS compliant |
| Front Hook | Aluminium alloy Al6082 and Al7075 |
| Rear Hook | Aluminium alloy Al 7075 |
| Connector | Aluminium alloy Al 6060 |
| Crossbeam | Aluminium alloy Al 7075 |
| Clamps | Aluminium alloy Al 7075 |
The main parts of the drive unit are as follows:
- For TWIST with front mounting without handlebar: drive wheel consisting of a brushless motor with tire and ● aluminium steering system
- For TWIST with front mounting with handlebar: drive wheel consisting of a brushless motor with tire and aluminium steering system connected to a handlebar
- . For TWIST with front mounting without handlebar: drive wheel consisting of a brushless motor with tire and aluminium steering system
- . For TWIST with rear mounting and TWIST R variation: drive wheel consisting of a brushless motor with tire, no steering.
- Electronic Control Unit / ECU (drive unit) for the motor and wireless interface for communication with controller or handlebar
- and optional smartphone WebApp
- Removable lithium ion battery pack with battery management system and recharge connector socket
- On/Off button and remaining capacity and operating mode indicator
- Carrying and release handle
- Battery charger
- Front and rear light
- Locking pins to connect the device to the connection system
{8}------------------------------------------------
Image /page/8/Picture/2 description: The image shows a logo with a stylized letter 'K' inside a hexagonal shape. The 'K' is formed by two downward-pointing arrows that meet in the middle. Below the shape, the word 'KLAXON' is written in a simple, sans-serif font. The logo is in black and white and appears to be a vector graphic.
The main parts of the controller are:
- Wireless interface for communicating with the ECU
- On/Off button
- Controller battery level LEDs indicator
- Speed selection lever and brake button
- Integrated Li-ION battery cell including battery management system
- USB-C socket for charging the controller
- Display for operating status and remaining capacity of drive unit and control unit
The main parts of the handlebar unit are:
- Wireless interface for communicating with the ECU ●
- On/Off button
- Controller battery level LEDs indicator ●
- Accelerator to adjust speed
- Brake lever for electronic brake (first part of the lever stroke)
- Brake lever for mechanical brake (second part of the lever stroke)
- Integrated Li-ION battery cell including battery management system
- USB-C socket for charging the controller
- . Display for operating status and remaining capacity of drive unit and control unit
To charge the battery of the drive unit a battery charger is available. Main attributes:
- Multi-range charger 100-240 VAC, 50-60 Hz ●
- Automatic charging and switch-off
- Indicating status
- Output 42V 2A
Drive Unit:
- Range: up to 21 km (13 mi) as per ISO 7176 4 ●
- . Nominal gradient: 10% [6°] - also note the limit values specified by the
wheelchair manufacturer.
- Maximum downhill grade: 10% [6°] also note the limit values specified by the wheelchair manufacturer ●
- Maximum speed front mounted with handlebar: 10 km/h (6.2 mph)
- Maximum speed front mounted without handlebar: 6 km/h (3.7 mph)
- Maximum speed rear mounted: Standard 6 km/h; Optional: 10 km/h (6.2 mph)
- Maximum speed for all configurations with attendant control: 6km/h (3.7 mph)
- Rated power of engine: 250 W
- Operating voltage (nominal): 36 VDC
- Operating temperature: -25° C to +50° C (-13° F to +122° F) ●
- Storage temperature: -40° C to +65° C (-40° F to +149° F)
- Weight of person: max. 120 kg (265 lbs)
- Protection rating: IPX4
{9}------------------------------------------------
510(K) SUMMARY
Image /page/9/Picture/2 description: The image is a logo for Klaxon. The logo is a stylized letter K inside of a hexagon. The word "KLAXON" is written below the letter K in a smaller font.
Battery pack:
- Cell type: Lithium-ion 21700 ●
- Rated operating capacity: 36 V
- Rated capacity: 4Ah
- Rated energy: 144 Wh
- Charging temperature: 0° C to +45° C (32° F to +113° F)
- Operating temperature: -25° C to +50° C (-13° F to +122° F)
- Protection rating: IPX4
Controller battery:
- Cell type: Lithium-ion 14500 ●
- . Rated voltage: 3.6 VDC
- . Rated capacity: 950 Ah
- Rated energy: 3.42 mWh
- Charging temperature: 0° C to +45° C (32° F to +113° F) ●
- Operating temperature: -25° C to +50° C (-13° F to +122° F)
Handlebar battery
- Cell type: Lithium-ion 18350 ●
- Rated voltage: 3.7 VDC ●
- Rated capacity: 1000 Ah
- Rated energy: 3.7 Wh
- Charging temperature: 0° C to +45° C (32° F to +113° F) ●
- . Operating temperature: -25° C to +50° C (-13° F to +122° F)
Main Battery Charger OFF BOARD
- Output voltage: 42 VDC ●
- . Output current: 2.0 A
- . Ambient temperature: Operation -20°C to +60°C (-4° F to +140° F)
- Ambient temperature: Storage -30°C to +80°C (-22° F to +176° F)
- Humidity: Operation 1% to 95%
- . Humidity: Storage 1% to 95%
- . Air pressure: Operation 750 to 1060 hPa (10.88 to 15.37 psi)
- . Air pressure: Storage 750 to 1060 hPa (10.88 to 15.37 psi)
Weight of the TWIST and TWIST R
- TWIST without handlebar (without battery): 7.4 kg (16.3 lbs) ●
- TWIST with handlebar (without battery): 9.8 kg (21.6 lbs)
- TWIST R (without battery): 6.5 kg (14.3 lbs)
- . Battery: 1.4 kg (3 lbs)
{10}------------------------------------------------
510(K) SUMMARY
Image /page/10/Picture/2 description: The image is a logo for Klaxon. The logo features a stylized letter "K" inside of a shield-like shape. The word "KLAXON" is written in smaller letters below the "K" inside the shield. The logo is in black and white.
2.5 WIRELESS TECHNOLOGY
2.5.1 Drive Unit:
- Type of wireless technology: EEE 802.15.4 (Bluetooth Low Energy)
- FCC compliance: Part 15c;
- FCC ID: 2AC7Z-ESP32WROOM32E
- . Wireless Coexistence Compliance: ANSI C63.27-2017, Tier 1
- EMC Compliance: ISO 7176-21
- . RF frequency range: 2.402 GHz to 2.480 GHz
- RF maximum output power: 9dBm
- Wireless operating range: 10m (32.8 ft) / class 2
- Wireless functions: Speed, Emergency stop, Operating mode (handlebar, controller, front, rear)
2.5.2 Controller:
- Type of wireless technology: IEEE 802.15.4 (Bluetooth Low Energy)
- FCC compliance: Part 15c;
- FCC ID: 2AC7Z-ESP32WROOM32E
- Wireless Coexistence Compliance: ANSI C63.27-2017, Tier 1
- . EMC Compliance: ISO 7176-21
- Wireless RF frequency range: 2.402 GHz to 2.480 GHz ●
- Wireless RF maximum output power: 9dBm
- Wireless operating range: 10m (32.8 ft) / class 2
- Wireless functions: Speed Level, Brake command, On/Off
2.5.3 Handlebar/Attendant control:
- . Type of wireless technology: IEEE 802.15.4 (Bluetooth Low Energy)
- FCC compliance: Part 15c;
- FCC ID: 2AC7Z-ESP32WROOM32E
- . Wireless Coexistence Compliance: ANSI C63.27-2017, Tier 1
- . EMC Compliance: ISO 7176-21
- . Wireless RF frequency range: 2.402 GHz to 2.480 GHz
- Wireless RF maximum output power: 9dBm
- Wireless operating range: 10m (32.8 ft) / class 2
- Wireless functions: Speed, Electronic Brake, On/Off
{11}------------------------------------------------
Image /page/11/Picture/2 description: The image is a logo for Klaxon. The logo is a stylized letter K inside of a shield-like shape. The word "KLAXON" is written in smaller letters below the K. The logo is black and white.
2.5.4 Cybersecurity Assessment
The Klaxon TWIST R use the wireless communication technology known as Bluetooth Low Energy (BLE). BLE allows two devices to exchange information in real time.
BLE is used to control the device at all times through the use of a controller or handlebar. The communication is encrypted and requires a preexisting pairing to activate the motor.
Due to the communication structure of the Klaxon TWIST R, the BLE communication happens in a different and independent control unit from the motor drive unit.
This means that in the unlikely event of a successful attack the device would be safely stopped and all power is removed from the motor. In this state no energy is provided to the motor and any unintended movement is impossible.
Even in the case of a successful attack to imitate a BLE command, the device would not be able of the established limits (speed, acceleration, braking, ecc.).
In the case unforeseen vulnerabilities are found, the firmware on the TWIST R can be fully patched remotely by the user using Over-The-Air updates.
Any vulnerabilities would not be exploited remotely and any attack requires that the device and that the attacker is within close physical proximity (i.e., within Bluetooth range) of the device.
The chipset used on the Klaxon TWIST R is up to date with modern vulnerabilities of the BLE stack and in particular already implements patches to the SweynTooth vulnerabilities.
The detail of the cybersecurity assessment according to FDA guidelines is available in the e-Star submission for the 510(k) K240267 (Klaxon TWIST and TWIST R).
{12}------------------------------------------------
Klaxon TWIST and TWIST R K240267
Image /page/12/Picture/3 description: The image shows a logo for Klaxon. The logo is a stylized letter K inside of a shield shape. The word "KLAXON" is written below the K in a smaller font size.
TECHNOLOGICAL COMPARISON BETWEEN THE SUBJECT DEVICE AND THE PREDICATE DEVICE 3
| Topic | Subject device | Predicate device | Substantial Equivalence Remarks |
|---|---|---|---|
| Indication For Use | The TWIST and TWIST R are add-on driveaccessories for wheelchairs.The TWIST and TWIST R devices areintended to provide auxiliary power tomanual wheelchairs to reduce thepushing power needed by their users.TWIST and TWIST R devices are designedto provide support to active wheelchairusers who are physically and mentallyable to safely control a manualwheelchair in typical situations, includinginclines, even manually. | The SMOOV O10 add-on drive forwheelchairs is intended to provideauxiliary power to manual wheelchairs toreduce the pushing power needed by theirusers.It is designed to provide support to activewheelchair users who are physically andmentally able to safely control a manualwheelchair in typicalsituations, including inclines, evenmanually. | There are no significant differencesbetween indications for use. |
| Intended Use | The TWIST and TWIST R are medicaldevices for active wheelchair users witha user weight of 120 kgs and who arereliant on a wheelchair as a result oftheir disability. The TWIST and TWIST Rare add-on drive for wheelchairs that areattached to a manual wheelchair,converting it into an electrically drivenwheelchair and thus significantlyincreasing the wheelchair user's mobilityand flexibility.The TWIST and TWIST R must always beused, transported, maintained andserviced carefully to keep theirperformance, efficiency and safety. TheTWIST and TWIST R must only beattached to and operated withwheelchairs that are selected by thespecialist dealer or by Klaxon itself. | The SMOOV O10 is a medical device foractive wheelchair users with a user weightof 140 kgs and who are reliant on awheelchair as a result of their disability.The SMOOV O10 is an add-on drive forwheelchairs that is attached to a manualwheelchair, converting it into anelectrically driven wheelchair and thussignific- antly increasing the wheelchairuser's mobility andflexibility.The SMOOV O10 must always be used,transported, maintained and servicedcarefully to keep its performance,efficiency and safety. The SMOOV O10must only be attached to and operatedwith wheelchairs that are listed in Alber'smounting database.The selection is made by the specialistdealer or by Alber itself. | There are no significant differences withregard to the intended use. |
| Permissible conditions ofuse/locations of operationType Environment of Use | -The TWIST and TWIST R devices aremanufactured to be coupled to themajority of wheelchairs on the market.- The TWIST and TWIST R devices can beused both indoors and outdoors, withinthe limits stated in the Instruction forUse document and, in general, accordingto the same limitations of use as thoseof the manual wheelchair (as establishedby its manufacturer)- Temperature range for use is minus 25to 50 °C (minus 13 to 122°F).Do not use TWIST and TWIST R deviceson slopes greater than 6°/10%. The ratedslope's limit shall be reduced inaccordance with the pavement and theenvironmental condition.- Maximum negotiable step is 30mm(1.18 inch).- TWIST and TWIST R must not be used ifnot coupled with a manual wheelchair. | Observe the permissible conditions of useof the wheelchair to which the SMOOV010 is attached.In addition to observing the informationprovided about the SMOOV O10, it is alsoimperative to observe the informationprovided by the wheelchair manufacturer(e.g. maximum gradeability, maximumpermissible height of obstacles, maximumuser weight, maximum speed, etc.). Thelowest values always apply.Any limits regarding the operation of yourwheelchair (e.g. maximum gradeability,maximum permissible height of obstacles,maximum user weight etc.) must also beobserved when using the SMOOV 010.The SMOOV O10 must only be operatedat temperatures between - 25 °C and +50°C. Therefore, do not expose the SMOOV010 to any heat sources (such as intensesunlight) as this may cause surfaces to | There are no differences affecting thesafety related to differences in thereported indications. |
{13}------------------------------------------------
Klaxon TWIST and TWIST R K240267
Image /page/13/Picture/3 description: The image is a logo for Klaxon. The logo features a stylized letter "K" inside of a shield-like shape. The word "KLAXON" is written in a smaller font below the "K".
| TWIST and TWIST R must not be usedafter intake of alcohol or if the user'spsycho- physical conditions areunsuitable.- TWIST and TWIST R must not be usedon roads with unsuitable pavement.- TWIST and TWIST R must not be usedin poor visibility (at night, in fog, etc.).- TWIST and TWIST R must not be used ifthe user weighs over 120 kg (265 lbs) oris heavier than allowed for thewheelchair used.- TWIST and TWIST R must not be usedin adverse weather (rain, strong wind,etc.). | The SMOOV O10 is designed for lightoutdoor use (e.g. solid pavement), avoidusing the wheelchair on soft ground (e.g.loose chipping, sand, mud, snow, ice ordeep puddles). | ||||||
|---|---|---|---|---|---|---|---|
| Market Segment | Active | Active | The Market segment is the same for boththe devices, thus the safety level isconsidered equivalent | ||||
| Introduced to the market | Spring 2022 (Europe) | spring 2019 | |||||
| Wheelchair Compatibility | Both rigid and foldable wheelchairs,instructions and eventual accessories aredepicted in the Installation Manualindications | Rigid W/C frames: Universal brackets onthe axle tubeFolding frames: adapter axle required | The wheelchair compatibility is formallythe same, thus the safety level isconsidered equivalent | ||||
| Available WheelchairWheel- Diameters (inch) | 22" - 26" front mount24" - 26" rear mount | 22" - 26" Rear mount | |||||
| Device Wheel Dimensions(inch) | Diameter: 10" | Diameter: 6.4"Width: 3,9" | |||||
| Max. user weight (kg) | 120 (265 lbs) | 140 (309 lbs) | The maximum allowed weight is lower for thesubject device | ||||
| System weight (kg) | Weight without batteryTWIST with handlebar: 9.8 (21.6 lbs)TWIST without handlebar: 7.4 (16,3 lbs)TWIST R: 6.5 (14.3 lbs)Battery weight: 1.4 (3 lbs) | 7.2 (15.9 lbs) | |||||
| Motor | Brushless motor | Brushless motor | The devices use the same technology, thusthe safety level is considered equivalent | ||||
| Battery | Lithium-Ion | Lithium-Ion | The devices use the same technology, thusthe safety level is considered equivalent | ||||
| Display | LEDs for battery levels, device'sStatus information and BT connection | LEDs for battery levels,device's status information andBT connection | The devices use the same technology, thusthe safety level is considered equivalent | ||||
| Nominal Power (Watt) | 250 | 250 | Same nominal Power, thus the safety level isconsidered equivalent | ||||
| Max. assisted Speed (km/h) | Nominal Range (km) | TWIST front with handlebar: 10 km/h (6.2mph)TWIST front without handlebar: 6 km/h (3.7mph)TWIST and TWIST R rear: 6 km/h (3.7mph);TWIST and TWIST R (optional): 10 km/h(6.2 mph) | 6 km/h (3.7 mph)Optional: 10 km/h (6.2 mph) | Same speedFOR HANDLEBAR THE COMMENT SHALL BEPROVIDED AFTER TUEV SUED TEST | |||
| 21 km (13 mi) | 20 km (12.4 mi) | Same declared range, thus the safety levelis considered equivalent | |||||
| Four (4) speeds selected by controller forall configurations without handlebar | Speed adjustments stepless via click wheel | The existing differences in the assist levelsare considered not to affect the safety |
{14}------------------------------------------------
Klaxon TWIST and TWIST R K240267
Image /page/14/Picture/3 description: The image is a logo for Klaxon. The logo features a stylized letter "K" inside of a shield shape. The word "KLAXON" is written below the letter "K" in a smaller font size. The logo is in black and white.
| Assist Levels | Speed adjustments are stepless viahandlebar's throttle | ||
|---|---|---|---|
| Controller/s | BLE remote controller for all versionswithout handlebar. | Bluetooth click wheel attached towheelchair | The devices use the same technology, thusthe safety level is considered equivalent |
| BLE remote controller with input fromthrottle and brake lever for handlebarversion | |||
| Adjustment of driveparameters | Controller:- Four (4) speed levels, stop pushbutton- ON/OFF button- Battery state of charge LEDsAttendant controller:- Throttle for managing the speed whenpushed and brake (front mounting) ordisengaging the motor when released.- ON/OFF buttonHandlebar:- Throttle for speed management- ON/OFF buttonMain battery:- ON/OFF button | Acceleration and speed depending on theangle of the drive wheel, Four (4)programmable driving modes. STOPpushbutton | The differences do not affect safety, thusthe safety level is considered equivalent |
| Smartphone App for enduser | WebApp for:- Drive information- ON/OFF light- Parameters change (within pre-setlimits), firmware updates over the air,failure and warnings | Android and iOSFree features:Cockpit, battery capacity, range, tourcomputer via GPS, four (4) programmabledriving modes, ON/OFF rear light,worldwide service contact details,firmware updates over the air, failure andwarningsChargeable: Navigation | In both cases, the App or WebApp is notnecessary to the functioning of the deviceand any change that can be done by user,is within safety limits imposed by themanufacturer. The safety level isconsidered the same. |
| Brake means | Front mounted with handlebar:- Mechanical brake- Electronic brake- Throttle release brakeFront mounted without handlebar:- Electronic brakeRear mounted:- No braking effect, only freewheelingmode. The brake effect is given by theuser acting on the wheel rims | No braking effect, only freewheelingmode. The brake effect is given by the useracting on the wheel rims | For subject device front mounted:The Subject device level of safety is higherbecause the user is always able tocompletely stop the device in anysituation.For subject device rear mounted:The safety level is considered the same forboth devices |
| Speed limit in downhill | Front mounted:The device limits the speed when ridingdown a slope according with the speedlevel selected or with the speed fixedwith the cruise control functionRear mounted:The system stops pushing (freewheelavailable) when the maximum speed isreached. There is no speed limit whenriding down a slope. | The system stops pushing when themaximum speed is reached. There is nospeed limit when riding down a slope. | For subject device front mounted:The subject device's level of safety isimproved because there is no risk toovercome the desired/fixed speed whenriding down a slope.For subject device rear mounted:The safety level is considered the same forboth devices |
| Front mounting:Mounted on the front of thewheelchair, the castor wheels arelifted off the ground 25mm to 40mm | Mounted on the rear of the wheelchair. Thecastor wheels are always in contact withthe ground | For subject device front mounted:The subject device's level of safety isimproved due to the minimum risk oftip over in case of ground | |
| Mounting Position | |||
| (0.98 inch to 1.58 inch)Rear mounting:Mounted on the rear of thewheelchair. The castor wheels arealways in contact with the ground | unevenness, curbs, obstacles (thisrisk is likely high on the predicatedevice). Moreover, the subjectdevice can limit the speed andeffectively brake when riding down aslope, due to the front mounting.For subject device rear mounted:The safety level is considered thesame for both devices |
{15}------------------------------------------------
510(K) SUMMARY
Image /page/15/Picture/2 description: The image shows a logo for Klaxon. The logo features a stylized letter K inside of a shield-like shape. The word "KLAXON" is written below the letter K in a smaller font size. The logo is in black and white.
{16}------------------------------------------------
510(K) SUMMARY
Image /page/16/Picture/2 description: The image is a logo for Klaxon. The logo is a shield shape with a stylized letter "K" inside. The word "KLAXON" is written below the "K" in a smaller font. The logo is black and white.
NON CLINICAL TESTING TO SUPPORT SUBSTANTIAL EQUIVALENCE 4
| Standard | Name | Recognition# |
|---|---|---|
| ISO 7176-1:2014 | Wheelchairs - Part 1: Determination of static stability | 16-195 |
| ISO 7176-2:2017 | Wheelchairs - Part 2:Determination of dynamic stability ofelectrically powered wheelchairs | 16-202 |
| ISO 7176-3:2012 | Wheelchairs - Part 3: Determination of effectiveness of brakes | 16-192 |
| ISO 7176-4:2008 | Wheelchairs - Part 4: Energy consumption of electric wheelchairsand scooters for determination of theoretical distance range | 16-162 |
| ISO 7176-6:2018 | Wheelchairs - Part 6: Determination of maximum speed ofelectrically powered wheelchairs | 16-204 |
| ISO 7176-8:2014 | Wheelchairs - Part 8: Requirements and test methods for static,impact and fatigue strengths | 16-197 |
| ISO 7176-9:2009 | Wheelchairs - Part 9: Climatic tests for electric wheelchairs | 16-167 |
| ISO 7176-10:2008 | Wheelchairs - Part 10: Determination of obstacle-climbing ability ofelectrically powered wheelchairs | 16-164 |
| ISO 7176-11:2012 | Wheelchairs - Part 11: Test dummies | 16-190 |
| ISO 7176-13:1989 | Wheelchairs - Part 13: Determination of coefficient of friction of testsurfaces | 16-25 |
| ISO 7176-14:2008 | Wheelchairs - Part 14: Power and control systems for electricallypowered wheelchairs and scooters - Requirements and testmethods | 16-165 |
| ISO 7176-15:1996 | Wheelchairs - Part 15: Requirements for information disclosure,documentation and labeling | 16-27 |
| ISO 7176-21:2009 | Wheelchairs - Part 21: Requirements and test methods forelectromagnetic compatibility of electrically powered wheelchairsand scooters, and battery chargers | 16-166 |
| ISO 7176-22:2014 | Wheelchairs - Part 22: Set-up procedures | 16-198 |
| ANSI USEMCSC C63.27-2021 | American National Standard for Evaluation of Wireless Coexistence | 19-48 |
| TIR69:2017/(R2020) | Technical Information Report Risk management of radio-frequencywireless coexistence for medical devices and systems. | 19-22 |
| EN 1041:2008 | Information supplied by the manufacturer of medical devices | |
| ISO 14971:2019 | Medical devices - Application of risk management to medical devices | 5-125 |
| EN 60335-2-29:2016 | Household and similar electrical appliances - Safety - Part 2-29: Particularrequirements for battery chargers | |
| UL 62133-2:2020 | Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made fromthem, for use in portable applications - Part 2: Lithium systems | |
| IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made fromthem, for use in portable applications - Part 2: Lithium systems | 19-33 |
| IEC 62304:2015 | Medical device software - Software life cycle processes (ed. 2006 as required by EN12184:2014 Standard, Including Amendment 1-2015) | 13-79 |
| UN 38.3 | Recommendations of the TRANSPORT OF DANGEROUS GOODS, Manual of Test andCriteria, Part III, Lithium metal and lithium ion batteries | |
| ETSI EN 301 489-17 V3.2.4 | Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part17: Specific conditions for Broadband Data Transmission Systems; Harmonized | |
| ETSI EN 301 489-1 V2.2.3 | Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part1: Common technical requirements; Harmonized Standard for ElectromagneticCompatibility | |
| ETSI EN 300 328 V2.2.2 | Wideband transmission systems; Data transmission equipment operating in the 2,4GHz band; Harmonized Standard for access to radio spectrum | |
| EN 62479:2010 | Assessment of the compliance of low-power electronic and electrical equipment withthe basic restrictions related to human exposure to electromagnetic fields (10 MHz to300 GHz) | |
| IEC 60601-1-2:2014+AMD1:2020 | Medical electrical equipment - Part 1-2: General requirements for basic safety andessential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests | 19-36 |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process | 2-258 |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | 2-245 |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization | 2-296 |
| ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation | 2-291 |
| EN 12184:2014 | Electrically poweredwheelchairs, scooters and theirchargers — Requirementsandtest methods |
{17}------------------------------------------------
Image /page/17/Picture/2 description: The image is a blank white canvas with a single, thin black line running horizontally across the top portion of the frame. The line is straight and appears to be of uniform thickness. The rest of the image is devoid of any other features or elements.
Image /page/17/Picture/3 description: The image shows a logo for Klaxon. The logo is a shield shape with a stylized letter "K" inside. The letter "K" is made up of two thick lines that meet at the top and angle downwards. The word "KLAXON" is written in small letters below the "K" inside the shield.
Klaxon TWIST and TWIST R K240267
CONCLUSION OF NON-CLINICAL TESTING 4.1
Both the predicate device SMOOV O10 and the subject TWIST R devices have been subjected to the same testing requirements, therefore Klaxon Mobility's subject device is substantially equivalent to the predicate, based on the results and demonstrated acceptable safety and performance.
§ 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).