Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electronic components of the device, with no mention of AI or ML capabilities for control or functionality.

Therapeutic

No.
The device provides auxiliary power to manual wheelchairs to reduce the pushing power needed by users, which is a functional enhancement rather than a direct therapeutic intervention.

Diagnostic

No

The device is described as an "add-on drive accessory for wheelchairs" that provides "auxiliary power to manual wheelchairs to reduce the pushing power needed by their users." There is no mention of it being used to diagnose any medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a drive wheel, motor, ECU, battery pack, buttons, lights, and a controller with a wireless interface and battery. This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by users. This is a mechanical and electrical function related to mobility, not a diagnostic test performed on biological samples.
Device Description: The description details mechanical and electrical components like a drive wheel, motor, battery, and controls. There is no mention of reagents, assays, or any components used for analyzing biological specimens.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on biological analysis.

The device is clearly a mobility aid designed to assist wheelchair users.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

ITI

Device Description

The TWIST and TWIST R are add-on drive accessories for wheelchairs. They provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users. These devices are designed to support active wheelchair users who can safely control a manual wheelchair, even on inclines.

The TWIST and TWIST R are medical devices intended for active wheelchair users weighing up to 120 kgs who rely on a wheelchair due to a disability. They attach to a manual wheelchair, converting it into an electrically driven one to increase mobility and flexibility. Proper use, transport, maintenance, and servicing are required to maintain their performance, efficiency, and safety. The TWIST R must only be used with wheelchairs selected by a specialist dealer or Klaxon.

There are two variations: TWIST and TWIST R. The TWIST has five possible configurations (front mounted without handlebar, user; front mounted without handlebar, attendant; rear mounted, user; rear mounted, attendant; front mounted with handlebar), while the TWIST R has two (rear mounted, user; rear mounted, attendant). All configurations have a 250W power output. Maximum speeds vary based on configuration, ranging from 6 km/h (3.7 mph) to 10 km/h (6.2 mph), with optional 10 km/h for certain rear-mounted configurations.

Materials used in the main components include aluminium alloy for the handlebar, hub frame, front hook, rear hook, crossbeam, and clamps; polyvinyl chloride (PVC) for handle grips. The ECU, Battery, and Hub motor are made of various RoHS compliant materials.

The main parts of the drive unit include:

Drive wheel with a brushless motor and tire, with an aluminium steering system for front mounting (with or without handlebar).
Drive wheel with a brushless motor and tire (no steering) for rear mounting and TWIST R variation.
Electronic Control Unit (ECU) for the motor and wireless communication with the controller or handlebar, and optional smartphone WebApp.
Removable lithium-ion battery pack with battery management system and recharge connector socket.
On/Off button and indicators for remaining capacity and operating mode.
Carrying and release handle.
Battery charger.
Front and rear light.
Locking pins for connection.

The main parts of the controller include:

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 with battery management system.
USB-C socket for charging.
Display for operating status and remaining capacity.

The main parts of the handlebar unit include:

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 stroke) and mechanical brake (second part of stroke).
Integrated Li-ION battery cell with battery management system.
USB-C socket for charging.
Display for operating status and remaining capacity.

The battery charger is a multi-range charger (100-240 VAC, 50-60 Hz) with automatic charging and switch-off, and status indication, with output 42V 2A.

Drive Unit specifications:

Range: up to 21 km (13 mi) as per ISO 7176-4.
Nominal gradient and maximum downhill grade: 10% [6°], subject to wheelchair manufacturer limits.
Maximum speed: 10 km/h (6.2 mph) for front mounted with handlebar; 6 km/h (3.7 mph) for front mounted without handlebar; standard 6 km/h (optional 10 km/h) for rear mounted; 6 km/h (3.7 mph) for all configurations with attendant control.
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).
Max user weight: 120 kg (265 lbs).
Protection rating: IPX4.

Battery pack specifications:

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 specifications:

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 specifications:

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 specifications:

Output voltage: 42 VDC.
Output current: 2.0 A.
Ambient temperature: Operation -20°C to +60°C (-4° F to +140° F); Storage -30°C to +80°C (-22° F to +176° F).
Humidity: Operation 1% to 95%; Storage 1% to 95%.
Air pressure: Operation and Storage 750 to 1060 hPa (10.88 to 15.37 psi).

Weight:

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).

Wireless technology: IEEE 802.15.4 (Bluetooth Low Energy) for Drive Unit, Controller, and Handlebar/Attendant control. All have FCC ID: 2AC7Z-ESP32WROOM32E, Wireless Coexistence Compliance: ANSI C63.27-2017, Tier 1, and 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 vary by unit (speed, emergency stop, operating mode; speed level, brake command, On/Off; speed, electronic brake, On/Off).

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

Not Found

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 was performed based on various ISO, ANSI, TIR, EN, UL, IEC, and UN standards. These standards cover aspects such as:

Wheelchairs - Determination of static stability (ISO 7176-1:2014)
Wheelchairs - Determination of dynamic stability of electrically powered wheelchairs (ISO 7176-2:2017)
Wheelchairs - Determination of effectiveness of brakes (ISO 7176-3:2012)
Wheelchairs - Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range (ISO 7176-4:2008)
Wheelchairs - Determination of maximum speed of electrically powered wheelchairs (ISO 7176-6:2018)
Wheelchairs - Requirements and test methods for static, impact and fatigue strengths (ISO 7176-8:2014)
Wheelchairs - Climatic tests for electric wheelchairs (ISO 7176-9:2009)
Wheelchairs - Determination of obstacle-climbing ability of electrically powered wheelchairs (ISO 7176-10:2008)
Wheelchairs - Test dummies (ISO 7176-11:2012)
Wheelchairs - Determination of coefficient of friction of test surfaces (ISO 7176-13:1989)
Wheelchairs - Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods (ISO 7176-14:2008)
Wheelchairs - Requirements for information disclosure, documentation and labeling (ISO 7176-15:1996)
Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers (ISO 7176-21:2009)
Wheelchairs - Set-up procedures (ISO 7176-22:2014)
American National Standard for Evaluation of Wireless Coexistence (ANSI USEMCSC C63.27-2021)
Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems (TIR69:2017/(R2020))
Information supplied by the manufacturer of medical devices (EN 1041:2008)
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Household and similar electrical appliances - Safety - Part 2-29: Particular requirements for battery chargers (EN 60335-2-29:2016)
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems (UL 62133-2:2020, IEC 62133-2:2017)
Medical device software - Software life cycle processes (IEC 62304:2015)
Recommendations of the TRANSPORT OF DANGEROUS GOODS, Manual of Test and Criteria, Part III, Lithium metal and lithium ion batteries (UN 38.3)
Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonized (ETSI EN 301 489-17 V3.2.4)
Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonized Standard for Electromagnetic Compatibility (ETSI EN 301 489-1 V2.2.3)
Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonized Standard for access to radio spectrum (ETSI EN 300 328 V2.2.2)
Assessment of the compliance of low-power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic fields (10 MHz to 300 GHz) (EN 62479:2010)
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014+AMD1:2020)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Electrically powered wheelchairs, scooters and their chargers — Requirements and test methods (EN 12184:2014)

Key results: Both the predicate device SMOOV O10 and the subject TWIST R devices have been subjected to the same testing requirements.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192016

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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)

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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

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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 | Commercial
name | Power
(W) | Max
speed
(km/h -
mph) | Combination | Notes |
|-----------|--------------------|--------------|---------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | TWIST | 250 | 6 – 3.7 | Front mounted
without handlebar,
user | The system is connected with the front
central connector, the castor wheels are
lifted off the ground.
The controller position is reachable by the
wheelchair's occupant. |
| 2 | TWIST | 250 | 6 - 3.7 | Front mounted
without handlebar,
attendant | The system is connected with the front
central connector, the castor wheels are
lifted off the ground.
The controller position is reachable by the
occupant'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 rear
connector, the castor wheels are on the
ground.
The controller position is reachable by the
wheelchair's occupant. |
|---|---------|-----|-----------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4 | TWIST | 250 | 6 – 3.7 | Rear mounted,
attendant | The system is connected with the rear
connector, the castor wheels are on the
ground.
The controller position is reachable by the
occupant's attendant. |
| 5 | TWIST | 250 | 10 – 6.2 | Front mounted with
handlebar | The system is connected with the front
central connector, the castor wheels are
lifted 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 rear
connector, the castor wheels are on the
ground.
The controller position is reachable by the
wheelchair's occupant. |
| 7 | TWIST R | 250 | 6 – 3.7 | Rear mounted,
attendant | The system is connected with the rear
connector, the castor wheels are on the
ground.
The controller position is reachable by the
occupant'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

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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 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 SMOOV O10 add-on drive for
wheelchairs is intended to provide
auxiliary power to manual wheelchairs to
reduce the pushing power needed by their
users.
It is 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.	There are no significant differences
between indications for use.
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 and 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 and TWIST R must only be
attached to and operated with
wheelchairs that are selected by the
specialist dealer or by Klaxon itself.	The SMOOV O10 is a medical device for
active wheelchair users with a user weight
of 140 kgs and who are reliant on a
wheelchair as a result of their disability.
The SMOOV O10 is an add-on drive for
wheelchairs that is attached to a manual
wheelchair, converting it into an
electrically driven wheelchair and thus
signific- antly increasing the wheelchair
user's mobility and
flexibility.
The SMOOV O10 must always be used,
transported, maintained and serviced
carefully to keep its performance,
efficiency and safety. The SMOOV O10
must only be attached to and operated
with wheelchairs that are listed in Alber's
mounting database.
The selection is made by the specialist
dealer or by Alber itself.	There are no significant differences with
regard to the intended use.
Permissible conditions of
use/locations of operation
Type Environment of Use	-The TWIST and TWIST R devices are
manufactured to be coupled to the
majority of wheelchairs on the market.

The TWIST and TWIST R devices can be
used both indoors and outdoors, within
the limits stated in the Instruction for
Use document and, in general, according
to the same limitations of use as those
of the manual wheelchair (as established
by its manufacturer)
Temperature range for use is minus 25
to 50 °C (minus 13 to 122°F).
Do not use TWIST and TWIST R devices
on slopes greater than 6°/10%. The rated
slope's limit shall be reduced in
accordance with the pavement and the
environmental condition.
Maximum negotiable step is 30mm
(1.18 inch).
TWIST and TWIST R must not be used if
not coupled with a manual wheelchair. | Observe the permissible conditions of use
of the wheelchair to which the SMOOV
010 is attached.
In addition to observing the information
provided about the SMOOV O10, it is also
imperative to observe the information
provided by the wheelchair manufacturer
(e.g. maximum gradeability, maximum
permissible height of obstacles, maximum
user weight, maximum speed, etc.). The
lowest values always apply.
Any limits regarding the operation of your
wheelchair (e.g. maximum gradeability,
maximum permissible height of obstacles,
maximum user weight etc.) must also be
observed when using the SMOOV 010.
The SMOOV O10 must only be operated
at temperatures between - 25 °C and +50
°C. Therefore, do not expose the SMOOV
010 to any heat sources (such as intense
sunlight) as this may cause surfaces to | There are no differences affecting the
safety related to differences in the
reported 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 used
after intake of alcohol or if the user's
psycho- physical conditions are
unsuitable.

TWIST and TWIST R must not be used
on roads with unsuitable pavement.
TWIST and TWIST R must not be used
in poor visibility (at night, in fog, etc.).
TWIST and TWIST R must not be used if
the user weighs over 120 kg (265 lbs) or
is heavier than allowed for the
wheelchair used.
TWIST and TWIST R must not be used
in adverse weather (rain, strong wind,
etc.). | The SMOOV O10 is designed for light
outdoor use (e.g. solid pavement), avoid
using the wheelchair on soft ground (e.g.
loose chipping, sand, mud, snow, ice or
deep puddles). | | | | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------|--|-----------------------------------------------------------------------------------|--|
| Market Segment | Active | Active | The Market segment is the same for both
the devices, thus the safety level is
considered equivalent | | | | |
| Introduced to the market | Spring 2022 (Europe) | spring 2019 | | | | | |
| Wheelchair Compatibility | Both rigid and foldable wheelchairs,
instructions and eventual accessories are
depicted in the Installation Manual
indications | Rigid W/C frames: Universal brackets on
the axle tube
Folding frames: adapter axle required | The wheelchair compatibility is formally
the same, thus the safety level is
considered equivalent | | | | |
| Available Wheelchair
Wheel- Diameters (inch) | 22" - 26" front mount

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 via
handlebar's throttle | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Controller/s | BLE remote controller for all versions
without handlebar. | Bluetooth click wheel attached to
wheelchair | The devices use the same technology, thus
the safety level is considered equivalent |
| | BLE remote controller with input from
throttle and brake lever for handlebar
version | | |
| Adjustment of drive
parameters | Controller:

Four (4) speed levels, stop pushbutton
ON/OFF button
Battery state of charge LEDs
Attendant controller:
Throttle for managing the speed when
pushed and brake (front mounting) or
disengaging the motor when released.
ON/OFF button
Handlebar:
Throttle for speed management
ON/OFF button
Main battery:
ON/OFF button | Acceleration and speed depending on the
angle of the drive wheel, Four (4)
programmable driving modes. STOP
pushbutton | The differences do not affect safety, thus
the safety level is considered equivalent |
| Smartphone App for end
user | WebApp for:
Drive information
ON/OFF light
Parameters change (within pre-set
limits), firmware updates over the air,
failure and warnings | Android and iOS
Free features:
Cockpit, battery capacity, range, tour
computer via GPS, four (4) programmable
driving modes, ON/OFF rear light,
worldwide service contact details,
firmware updates over the air, failure and
warnings
Chargeable: Navigation | In both cases, the App or WebApp is not
necessary to the functioning of the device
and any change that can be done by user,
is within safety limits imposed by the
manufacturer. The safety level is
considered the same. |
| Brake means | Front mounted with handlebar:
Mechanical brake
Electronic brake
Throttle release brake
Front mounted without handlebar:
Electronic brake
Rear mounted:
No braking effect, only freewheeling
mode. The brake effect is given by the
user acting on the wheel rims | No braking effect, only freewheeling
mode. The brake effect is given by the user
acting on the wheel rims | For subject device front mounted:
The Subject device level of safety is higher
because the user is always able to
completely stop the device in any
situation.
For subject device rear mounted:
The safety level is considered the same for
both devices |
| Speed limit in downhill | Front mounted:
The device limits the speed when riding
down a slope according with the speed
level selected or with the speed fixed
with the cruise control function
Rear mounted:
The system stops pushing (freewheel
available) when the maximum speed is
reached. There is no speed limit when
riding down a slope. | The system stops pushing when the
maximum speed is reached. There is no
speed limit when riding down a slope. | For subject device front mounted:
The subject device's level of safety is
improved because there is no risk to
overcome the desired/fixed speed when
riding down a slope.
For subject device rear mounted:
The safety level is considered the same for
both devices |
| | Front mounting:
Mounted on the front of the
wheelchair, the castor wheels are
lifted off the ground 25mm to 40mm | Mounted on the rear of the wheelchair. The
castor wheels are always in contact with
the ground | For subject device front mounted:
The subject device's level of safety is
improved due to the minimum risk of
tip over in case of ground |
| Mounting Position | | | |
| | (0.98 inch to 1.58 inch)
Rear mounting:
Mounted on the rear of the
wheelchair. The castor wheels are
always in contact with the ground | unevenness, curbs, obstacles (this
risk is likely high on the predicate
device). Moreover, the subject
device can limit the speed and
effectively brake when riding down a
slope, due to the front mounting.

For subject device rear mounted:
The safety level is considered the
same 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 of
electrically 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 wheelchairs
and scooters for determination of theoretical distance range	16-162
ISO 7176-6:2018	Wheelchairs - Part 6: Determination of maximum speed of
electrically 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 of
electrically 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 test
surfaces	16-25
ISO 7176-14:2008	Wheelchairs - Part 14: Power and control systems for electrically
powered wheelchairs and scooters - Requirements and test
methods	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 for
electromagnetic compatibility of electrically powered wheelchairs
and 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-frequency
wireless 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: Particular
requirements 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 from
them, 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 from
them, 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 EN
12184:2014 Standard, Including Amendment 1-2015)	13-79
UN 38.3	Recommendations of the TRANSPORT OF DANGEROUS GOODS, Manual of Test and
Criteria, 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; Part
17: 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; Part
1: Common technical requirements; Harmonized Standard for Electromagnetic
Compatibility
ETSI EN 300 328 V2.2.2	Wideband transmission systems; Data transmission equipment operating in the 2,4
GHz band; Harmonized Standard for access to radio spectrum
EN 62479:2010	Assessment of the compliance of low-power electronic and electrical equipment with
the basic restrictions related to human exposure to electromagnetic fields (10 MHz to
300 GHz)
IEC 60601-1-
2:2014+AMD1:2020	Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential 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 risk
management 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 — Requirements
andtest 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.